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Non-conventional Treatment of Mood Disorders What the evidence suggests 21 st Annual DBSA Conference 15 October 2011 Non-conventional Treatment of Mood.

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Presentation on theme: "Non-conventional Treatment of Mood Disorders What the evidence suggests 21 st Annual DBSA Conference 15 October 2011 Non-conventional Treatment of Mood."— Presentation transcript:

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2 Non-conventional Treatment of Mood Disorders What the evidence suggests 21 st Annual DBSA Conference 15 October 2011 Non-conventional Treatment of Mood Disorders What the evidence suggests 21 st Annual DBSA Conference 15 October 2011 James Lake, MD Private Practice, Monterey Chair, International Network of Integrative Mental Health (www.INIMH.org) www.INIMH.org

3 Disclosures none none

4 Definitions Conventional treatmentsaccepted in mainstream medicine (emphasis is on prescription drugs and psychotherapy) Conventional treatmentsaccepted in mainstream medicine (emphasis is on prescription drugs and psychotherapy) CAM (complementary and alternative) treatmentsnot currently accepted in mainstream medicine (egs: herbs, other natural products, acupuncture, yoga) CAM (complementary and alternative) treatmentsnot currently accepted in mainstream medicine (egs: herbs, other natural products, acupuncture, yoga) Integrative treatmentscombinations of conventional and CAM treatments Integrative treatmentscombinations of conventional and CAM treatments

5 CAM Rx trends in mental health Two thirds of patients hospitalized for a mental health problem used a CAM therapy within the past year (Elkins et al., 2005) Two thirds of patients hospitalized for a mental health problem used a CAM therapy within the past year (Elkins et al., 2005) Few patients disclose CAM use to family physician or psychiatrist resulting in treatment failures, delays and safety issues (Eisenberg et al., 1998; Kessler et al., 2001) Few patients disclose CAM use to family physician or psychiatrist resulting in treatment failures, delays and safety issues (Eisenberg et al., 1998; Kessler et al., 2001)

6 Integrative Rxconsiderations Psychiatrists and CAM practitioners should be familiar with evidence for CAM/integrative Rx choices to give appropriate, safe advice Psychiatrists and CAM practitioners should be familiar with evidence for CAM/integrative Rx choices to give appropriate, safe advice Most appropriate Rx determined by Most appropriate Rx determined by –sx type and severity –co-morbid medical or psychiatric DO –previous conventional and CAM Rx and response –Personal, cultural preferences –cost and local availability

7 Integrative RxBasics When previous Rx not effective or no previous similar episode, start with most validated Rx targeting core symptom(s) When previous Rx not effective or no previous similar episode, start with most validated Rx targeting core symptom(s) For severe sx always start Rx with first-line conventional medications For severe sx always start Rx with first-line conventional medications For moderate sx consider evidence-based use of adjunctive CAM Rx For moderate sx consider evidence-based use of adjunctive CAM Rx When initial Rx ineffective consider conventional or CAM Rx with pt signed informed consent of risks and benefits When initial Rx ineffective consider conventional or CAM Rx with pt signed informed consent of risks and benefits

8 Alternative and Integrative Treatments of Depressed Mood What the evidence suggests

9 Emerging context of CAM Rx for depressed mood CAM use greater among individuals diagnosed with any DSM-IV disorder (Unutzer 2000) CAM use greater among individuals diagnosed with any DSM-IV disorder (Unutzer 2000) Limited efficacy of conventional Rx in severe depression; no benefit in moderate depression (Kirsch 2008) Limited efficacy of conventional Rx in severe depression; no benefit in moderate depression (Kirsch 2008) Two thirds of severely depressed outpatients use CAM Rx while taking prescription medications (Kessler 2001) Two thirds of severely depressed outpatients use CAM Rx while taking prescription medications (Kessler 2001)

10 CAM Rx in Depressed mood –Vitamins –St. Johns wort –Omega-3 fatty acids –SAMe –Amino acids –DHEA –Light therapy –Acupuncture –Exercise

11 Folate, B-12, thiamin and D In depressed mood

12 Folate Studies of folate (1 to 5mg) in depressed populations (elderly, concurrent alcohol dependence, concurrent dementia) consistently show significant improvement (Guaraldi et al., 1993; Di Palma et al., 1994; Glória et al., 1997; Passeri et al., 1993) Studies of folate (1 to 5mg) in depressed populations (elderly, concurrent alcohol dependence, concurrent dementia) consistently show significant improvement (Guaraldi et al., 1993; Di Palma et al., 1994; Glória et al., 1997; Passeri et al., 1993) Folate as add-on to antidepressant in folate deficient depressed patients (N = 24) showed more improvement than placebo (Godfrey et al., 1990) Folate as add-on to antidepressant in folate deficient depressed patients (N = 24) showed more improvement than placebo (Godfrey et al., 1990)

13 Folatetreatment issues Folate taken alone is probably beneficial Folate taken alone is probably beneficial More studies needed to confirm optimal form and dosing More studies needed to confirm optimal form and dosing Adding to antidepressants is reasonable when treating depressed folate deficient patients Adding to antidepressants is reasonable when treating depressed folate deficient patients Partial responders to antidepressants may benefit by adding folate Partial responders to antidepressants may benefit by adding folate Depressed individuals with normal folate levels may benefit from folate or methylfolate Depressed individuals with normal folate levels may benefit from folate or methylfolate

14 B-12, thiamin Patients with higher B 12 levels show more robust response to antidepressants (Hintikka 2003) Patients with higher B 12 levels show more robust response to antidepressants (Hintikka 2003) Oral B 12 (800 μg/d) suggested as add- on Rx to antidepressants Oral B 12 (800 μg/d) suggested as add- on Rx to antidepressants Some report consistent improvements in mood and energy with daily thiamin (50-mg) Some report consistent improvements in mood and energy with daily thiamin (50-mg)

15 Vitamin D Literature review supports association between depressed mood and low vitamin D levels (Parker & Brotchie 2011) however… Literature review supports association between depressed mood and low vitamin D levels (Parker & Brotchie 2011) however… Not clear whether deficiency is cause or effect of depressed mood Not clear whether deficiency is cause or effect of depressed mood Possible association with SAD not rigorously examined Possible association with SAD not rigorously examined Insufficient research to support vitamin D augmentation with antidepressants Insufficient research to support vitamin D augmentation with antidepressants Bottom line: insufficient evidence for vitamin D supplementation in depressed patients, but reasonable for depressed patients at risk of vitamin D insufficiency or where low vitamin D levels found Bottom line: insufficient evidence for vitamin D supplementation in depressed patients, but reasonable for depressed patients at risk of vitamin D insufficiency or where low vitamin D levels found

16 St. Johns wort (Hypericum perforatum) In depressed mood

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18 St. Johns Wort Meta-analysis of controlled trials on SJW found serious design problems and inconsistent outcomes (Linde et al., 2005) Meta-analysis of controlled trials on SJW found serious design problems and inconsistent outcomes (Linde et al., 2005) Two large well designed studies found no difference between SJW and placebo on primary outcome measures in MDD (Shelton et al., 2001; Hypericum Study Group, 2002) Two large well designed studies found no difference between SJW and placebo on primary outcome measures in MDD (Shelton et al., 2001; Hypericum Study Group, 2002) However…another large trial found significant difference between SJW and placebo in mild- moderate depression (Lecrubier et al., 2002). However…another large trial found significant difference between SJW and placebo in mild- moderate depression (Lecrubier et al., 2002).

19 St. Johns worttreatment issues Safety issuesinduces liver enzymes lowering blood levels of anti-HIV drugs, cancer drugs, anticoagulants, digoxin, OCPs and hormones (Roby et al., 2000; Mannel et al., 2004) Safety issuesinduces liver enzymes lowering blood levels of anti-HIV drugs, cancer drugs, anticoagulants, digoxin, OCPs and hormones (Roby et al., 2000; Mannel et al., 2004) Reasonable for mild to moderate depression, however recent U.S. studies do not show efficacy over placebo Reasonable for mild to moderate depression, however recent U.S. studies do not show efficacy over placebo Drug interactions limit use and pose safety considerations Drug interactions limit use and pose safety considerations

20 Essential fatty acids In depressed mood

21 Omega-3sgeneral health benefits Fish, algae and flaxseed oil Fish, algae and flaxseed oil Deficient in average American diet Deficient in average American diet Cardiovascular benefitsdecrease risk of stroke and arrhythmias, reduce triglycerides, decrease atherosclerosis (Kris-Etherton 2003) Cardiovascular benefitsdecrease risk of stroke and arrhythmias, reduce triglycerides, decrease atherosclerosis (Kris-Etherton 2003) AHA recommends fish twice weekly, and 1 g/day EPA + DHA for heart disease (Kris- Etherton 2003) AHA recommends fish twice weekly, and 1 g/day EPA + DHA for heart disease (Kris- Etherton 2003) May reduce oxidative brain damage and slow age-related cognitive decline (Cole 2005; Morris 2005) May reduce oxidative brain damage and slow age-related cognitive decline (Cole 2005; Morris 2005)

22 Omega-3s in depressed mood Meta-analyses show benefits in unipolar and bipolar depression (Parker 2006; Freeman 2006; Lin and Su 2007) Meta-analyses show benefits in unipolar and bipolar depression (Parker 2006; Freeman 2006; Lin and Su 2007) However…results difficult to interpret due to However…results difficult to interpret due to –Inconsistent findings –Different study designs Stand-alone vs. add-on therapy EPA vs DHA vs both Omega-3s Variability in dosing Variability in study length

23 Omega-3s in depressed mood DHA as monotherapy in depressed adults: no benefit over placebo (Marangell et al., 2003) DHA as monotherapy in depressed adults: no benefit over placebo (Marangell et al., 2003) DHA/EPA monotherapy in depressed children: moderate benefit over placebo (Nemets et al., 2006) DHA/EPA monotherapy in depressed children: moderate benefit over placebo (Nemets et al., 2006) DHA/EPA add-on to antidepressants: no benefit over placebo (DHA dose higher than EPA) (Grenyer et al., 2007) DHA/EPA add-on to antidepressants: no benefit over placebo (DHA dose higher than EPA) (Grenyer et al., 2007) EPA (1 g) alone vs Prozac (20 mg) vs EPA + Prozac: similar efficacy with EPA and Prozac. Combined Rx superior to either (Jazayeri 2008) EPA (1 g) alone vs Prozac (20 mg) vs EPA + Prozac: similar efficacy with EPA and Prozac. Combined Rx superior to either (Jazayeri 2008)

24 Omega-3s in depression bottom line Low-risk add-on therapy for depressed patients with significant cardiovascular and health benefits endorsed by APA (Freeman 2006) Low-risk add-on therapy for depressed patients with significant cardiovascular and health benefits endorsed by APA (Freeman 2006) Most findings support lower doses (1-2 gm/day) Most findings support lower doses (1-2 gm/day) Add-on EPA or EPA/DHA probably most beneficial, less evidence for DHA alone Add-on EPA or EPA/DHA probably most beneficial, less evidence for DHA alone Stand-alone omega-3s in depression more effective with EPA alone or EPA>DHA Stand-alone omega-3s in depression more effective with EPA alone or EPA>DHA

25 S-adenosyl-methionine (SAMe) In depressed mood

26 SAMe Equal efficacy of IV or oral SAMe and antidepressants with good tolerance (Delle Chiaie 2002; Pancheri 2002) Equal efficacy of IV or oral SAMe and antidepressants with good tolerance (Delle Chiaie 2002; Pancheri 2002) Meta-analysis of controlled trials (total patients=1,015)no significant differences in outcomes between SAMe and antidepressants (AHRQ Publication 2002; http://www.ahrq.gov) Meta-analysis of controlled trials (total patients=1,015)no significant differences in outcomes between SAMe and antidepressants (AHRQ Publication 2002; http://www.ahrq.gov)

27 SAMetreatment issues Stability is issuedegrades rapidly over several months on shelf. (Spillmann 1996) Stability is issuedegrades rapidly over several months on shelf. (Spillmann 1996) Adverse effects: insomnia, lack of appetite, constipation, nausea, dry mouth, sweating, dizziness, and nervousness (Spillmann 1996) Adverse effects: insomnia, lack of appetite, constipation, nausea, dry mouth, sweating, dizziness, and nervousness (Spillmann 1996) Small % responders switch to mania (Carney 1987) Small % responders switch to mania (Carney 1987)

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29 Amino acids and DHEA Amino acids: L-tryptophan, 5- HTP, tyrosine, Acetyl-L-carnitine DHEA is a prohormone

30 L-tryptophan and 5-HTP L-tryp and 5-HTP both +/- effective but 5- HTP crosses blood-brain barrier at higher rate, converted into serotonin more efficiently, and greater antidepressant effect L-tryp and 5-HTP both +/- effective but 5- HTP crosses blood-brain barrier at higher rate, converted into serotonin more efficiently, and greater antidepressant effect Antidepressant effect starts between 100mg and 300mg/day Antidepressant effect starts between 100mg and 300mg/day >15 controlled trials show consistent positive effects in moderate depressed mood (Birdsall 1998) >15 controlled trials show consistent positive effects in moderate depressed mood (Birdsall 1998)

31 5-HTP 63 depressed patients randomized to fluvoxamine 150mg vs 5-HTP 300mg similar improvements in mood (Poldinger 1991) 63 depressed patients randomized to fluvoxamine 150mg vs 5-HTP 300mg similar improvements in mood (Poldinger 1991) Case reports Rx-refractory pts improving when 5-HTP 300mg combined with TCAs, MAOIs or SSRIs; no serious side effects reported (van Praag 1984; Sargent 1998; Kline 1980; Mendlewicz 1980) Case reports Rx-refractory pts improving when 5-HTP 300mg combined with TCAs, MAOIs or SSRIs; no serious side effects reported (van Praag 1984; Sargent 1998; Kline 1980; Mendlewicz 1980)

32 L-tyrosine Obtained through diet or synthesized from phenylalanine; essential precursor for synthesis of epinephrine, norepinephrine and dopamine Obtained through diet or synthesized from phenylalanine; essential precursor for synthesis of epinephrine, norepinephrine and dopamine Essential for synthesis of NGF and thyroxin Essential for synthesis of NGF and thyroxin Deficiency frequent in depressed mood (Grevet 2002) Deficiency frequent in depressed mood (Grevet 2002) Beneficial doses 500-1500mg/day Beneficial doses 500-1500mg/day Cautionhigh doses increase cancer risk (Harvie 2002) Cautionhigh doses increase cancer risk (Harvie 2002)

33 Acetyl-L-carnitine (ALC) Neuroprotective, may reduce cognitive impairments in normal aging, dementia, and traumatic brain injury Neuroprotective, may reduce cognitive impairments in normal aging, dementia, and traumatic brain injury Depressed demented patients taking 2-3gm/day reported greater improvements in mood and global functioning than placebo (Bella 1990) Depressed demented patients taking 2-3gm/day reported greater improvements in mood and global functioning than placebo (Bella 1990) Severely depressed elderly patients taking 500-mg 4x/day achieved full remission (Gecele 1991) Severely depressed elderly patients taking 500-mg 4x/day achieved full remission (Gecele 1991) Few or no adverse effects; can be safely combined with antidepressants Few or no adverse effects; can be safely combined with antidepressants

34 Dihydroepiandosterone (DHEA) Pro-hormone. Mechanism involves serotonin, GABA, NMDA, other neurotransmitters Pro-hormone. Mechanism involves serotonin, GABA, NMDA, other neurotransmitters 30mg 2x/day 50% reduction in sx severity (most remained on antidepressants) 30mg 2x/day 50% reduction in sx severity (most remained on antidepressants) Moderately depressed adults given 90-mg 3 wks followed by 150-mg 3x/day 3 wks reported 50% sx reduction, improved sexual fx (Schmidt 2005) Moderately depressed adults given 90-mg 3 wks followed by 150-mg 3x/day 3 wks reported 50% sx reduction, improved sexual fx (Schmidt 2005) Depressed HIV positive patients taking 200 to 500 mg/day reported significant improvements in mood and fatigue (Rabkin 2000) Depressed HIV positive patients taking 200 to 500 mg/day reported significant improvements in mood and fatigue (Rabkin 2000).

35 Light exposure therapy In depressed mood

36 Bright light exposure therapy Systematic reviewall published studies on bright light exposure for non-seasonal depression found modest…promising anti- depressive efficacy, especially when administered during the first week of treatment, in the morning, and as an adjunctive treatment to sleep deprivation responders (Tuuainen 2004). Systematic reviewall published studies on bright light exposure for non-seasonal depression found modest…promising anti- depressive efficacy, especially when administered during the first week of treatment, in the morning, and as an adjunctive treatment to sleep deprivation responders (Tuuainen 2004).

37 Bright light exposure therapy More recent reviews report mixed findings More recent reviews report mixed findings Comparable efficacy of bright light and antidepressants for SAD and non- seasonal depressed mood Comparable efficacy of bright light and antidepressants for SAD and non- seasonal depressed mood Ineffective alone but may improve response when combined with antidepressant in non-seasonal depression (Golden 2005; Even 2008) Ineffective alone but may improve response when combined with antidepressant in non-seasonal depression (Golden 2005; Even 2008)

38 Light exposuretreatment issues Mechanism unclearfull-spectrum bright light probably modulates CNS melatonin, serotonin and dopamine (Neumeister 2004). Mechanism unclearfull-spectrum bright light probably modulates CNS melatonin, serotonin and dopamine (Neumeister 2004). Safe effective alternative to antidepressants in pregnant depressed women (Epperson 2004) Safe effective alternative to antidepressants in pregnant depressed women (Epperson 2004) Uncommon side effects: jitteriness, headaches (10%), mild nausea (16%) (Terman 2005) Uncommon side effects: jitteriness, headaches (10%), mild nausea (16%) (Terman 2005) Sporadic cases of hypomania reported (Epperson et al., 2004; Terman 2005) Sporadic cases of hypomania reported (Epperson et al., 2004; Terman 2005)

39 Acupuncture In depressed mood

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41 Acupuncture Efficacy difficult to evaluate due to: Efficacy difficult to evaluate due to: –Differences in study designs –Concurrent use of other conventional or CAM Rx –Different Chinese vs Western medical diagnoses –Use of different acupuncture protocols Most systematic reviews included only English language studies (Mukaino 2005; Smith and Hay, 2005; Leo and Ligot, 2007) Most systematic reviews included only English language studies (Mukaino 2005; Smith and Hay, 2005; Leo and Ligot, 2007)

42 Acupunctureresearch and Rx issues No significant clinical differences between manual acupuncture and electro- acupuncture and sham or waitlist. No significant clinical differences between manual acupuncture and electro- acupuncture and sham or waitlist. Insufficient data to conclude differences in efficacy of acupuncture vs antidepressants Insufficient data to conclude differences in efficacy of acupuncture vs antidepressants Uncommon adverse effects: bruising, fatigue, nausea. Rare serious risks: HIV, hepatitis B and C (Vincent 2001) Uncommon adverse effects: bruising, fatigue, nausea. Rare serious risks: HIV, hepatitis B and C (Vincent 2001)

43 Research and treatment issues No agreement on standardized sham acupuncture No agreement on standardized sham acupuncture Possible beneficial effects from stimulating specific acu-points used as sham points Possible beneficial effects from stimulating specific acu-points used as sham points Significant differences in type of acupuncture, duration, frequency and number of sessions limit analysis of pooled treatment outcomes from different study designs Significant differences in type of acupuncture, duration, frequency and number of sessions limit analysis of pooled treatment outcomes from different study designs

44 Exercise In depressed mood

45 Exercise Treatment studies consistently show benefit of aerobic exercise (Dunn 2005; Penninx 2002; Mather 2002; Herman 2002) Treatment studies consistently show benefit of aerobic exercise (Dunn 2005; Penninx 2002; Mather 2002; Herman 2002) Some studies show mood benefits of resistance training (Singh 2005; Singh 2001) Some studies show mood benefits of resistance training (Singh 2005; Singh 2001) Beneficial effects of exercise on mood may be sustained over time (Babyak 2000) Beneficial effects of exercise on mood may be sustained over time (Babyak 2000) Long-term longitudinal studies needed Long-term longitudinal studies needed

46 Alternative and Integrative Treatments of Bipolar Disorder What the evidence suggests

47 Conventional Rxlimitations 50% of BD pts discontinue Rx because of AEs: tremor, weight gain, elevated liver enzymes (Fleck et al., 2005) 50% of BD pts discontinue Rx because of AEs: tremor, weight gain, elevated liver enzymes (Fleck et al., 2005) High relapse rate in BD pts on maintenance mood stabilizers (Boschert 2004) High relapse rate in BD pts on maintenance mood stabilizers (Boschert 2004)

48 CAM use in Bipolar Disorder High % BD pts use CAM together with prescription Rx (Andreescu 2008) High % BD pts use CAM together with prescription Rx (Andreescu 2008) Weak evidence for most CAM Rx (Ernst 2003; Dennehy 2004) Weak evidence for most CAM Rx (Ernst 2003; Dennehy 2004) BD pts may be at high risk for AEs due to concurrent use of conventional Rx (Vazquez 2002; Izzo 2004) BD pts may be at high risk for AEs due to concurrent use of conventional Rx (Vazquez 2002; Izzo 2004)

49 Non-conventional Rx Exercise Exercise Omega-3 EFAs Omega-3 EFAs N-acetyl-cysteine N-acetyl-cysteine Adjunctive folate in acute mania Adjunctive folate in acute mania Adding choline to lithium Adding choline to lithium Trace lithium Trace lithium Proprietary nutrient formula Proprietary nutrient formula St. Johns wort plus bright light in SAD St. Johns wort plus bright light in SAD Acupuncture Acupuncture

50 Exercise Adjunctive (plus medication) exercise may increase in brain-derived neurotrophic factor stimulating increased neurogenesis (Sylvia et al. 2009) Adjunctive (plus medication) exercise may increase in brain-derived neurotrophic factor stimulating increased neurogenesis (Sylvia et al. 2009) But…BD pts who exercise probably have healthier lifestyles than non-exercisers (causality difficult to establish) But…BD pts who exercise probably have healthier lifestyles than non-exercisers (causality difficult to establish) Large prospective trials needed to determine effect size Large prospective trials needed to determine effect size

51 Omega-3 fatty acids 4-mo PCRT (N=30) BD pts treated with Omega-3s (9.6gm/d) vs placebo while continuing mood stabilizers (Stoll 1999) 4-mo PCRT (N=30) BD pts treated with Omega-3s (9.6gm/d) vs placebo while continuing mood stabilizers (Stoll 1999) Omega-3 group remained in remission significantly longer than placebo Omega-3 group remained in remission significantly longer than placebo Pts taking Omega-3 fatty acids only remained in remission significantly longer than placebo group Pts taking Omega-3 fatty acids only remained in remission significantly longer than placebo group

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53 Review findingsomega-3s in Bipolar Disorder 5 studies met inclusion criteria however uneven quality (Montgomery & Richardson 2008) 5 studies met inclusion criteria however uneven quality (Montgomery & Richardson 2008) One study (N= 75) adequate quality/size for analysissmall benefit of omega-3s over placebo for depressive phase not mania One study (N= 75) adequate quality/size for analysissmall benefit of omega-3s over placebo for depressive phase not mania CONCLUSIONS: Findings must be regarded with caution due to limited data. Acute need for well-designed adequately powered PCRTs CONCLUSIONS: Findings must be regarded with caution due to limited data. Acute need for well-designed adequately powered PCRTs

54 Omega-3 fatty acidssafety issues Case report of hypomania induced by high doses of omega-3s (Kinrys 2000) Case report of hypomania induced by high doses of omega-3s (Kinrys 2000) Rare cases of increased bleeding times, but not increased bleeding risk in pts taking aspirin or anti-coagulants Rare cases of increased bleeding times, but not increased bleeding risk in pts taking aspirin or anti-coagulants Omega-3s should be regarded as viable adjuvant Rx of mania and bipolar illness Omega-3s should be regarded as viable adjuvant Rx of mania and bipolar illness

55 N-acetyl cysteine (NAC) Amino acid with strong anti-oxidant properties used to treat inflammatory disorders (Dodd, Dean et al. 2008) Amino acid with strong anti-oxidant properties used to treat inflammatory disorders (Dodd, Dean et al. 2008) May reduce symptoms of depressed mood but not mania in stable bipolar patients when combined with mood stabilizers May reduce symptoms of depressed mood but not mania in stable bipolar patients when combined with mood stabilizers 24-week PCRT (N=75) stable BD patients taking NAC (1g/d) vs placebo with mood stabilizer showed significant improvements in depression (Berk et al 2008). 24-week PCRT (N=75) stable BD patients taking NAC (1g/d) vs placebo with mood stabilizer showed significant improvements in depression (Berk et al 2008). Non-significant improvements in mania Non-significant improvements in mania

56 Folate + Valproic acid in acute mania 3 week DBPCT (N=88) BD I manic patients randomized to folic acid (3mg) + valproate vs placebo + valproate (Behzadi et al. 2009) 3 week DBPCT (N=88) BD I manic patients randomized to folic acid (3mg) + valproate vs placebo + valproate (Behzadi et al. 2009) Statistically significant difference in YMRS at 3 weeks suggesting folate effective adjuvant to valproate in acute mania Statistically significant difference in YMRS at 3 weeks suggesting folate effective adjuvant to valproate in acute mania

57 Adding choline to lithium Choline is required for biosynthesis of acetylcholine (Ach); low Ach levels are known cause of mania (Leiva 1990). Choline is required for biosynthesis of acetylcholine (Ach); low Ach levels are known cause of mania (Leiva 1990). Case study of Rx-refractory rapid- cycling BD pts taking lithiumfour of six responded to addition of 2,000- 7,200 mg/day free choline (Stoll 1996) Case study of Rx-refractory rapid- cycling BD pts taking lithiumfour of six responded to addition of 2,000- 7,200 mg/day free choline (Stoll 1996) Need large DB prospective studies Need large DB prospective studies

58 Adding choline to lithium Small PCRT found phosphatidylcholine 15gm to 30gm/day reduces severity of both mania and depressed mood in BD pts (Stoll 1996) Small PCRT found phosphatidylcholine 15gm to 30gm/day reduces severity of both mania and depressed mood in BD pts (Stoll 1996) Sx recurred when Rx discontinued Sx recurred when Rx discontinued

59 Trace lithium supplementation Small open study suggests BD I pts with mania or depressed mood improve with low doses (50 micrograms/meal) of a natural lithium preparation (Fierro 1988) Small open study suggests BD I pts with mania or depressed mood improve with low doses (50 micrograms/meal) of a natural lithium preparation (Fierro 1988) Responders had undetectable post-Rx serum Li+ levels Responders had undetectable post-Rx serum Li+ levels Need large PCRTs to replicate findings Need large PCRTs to replicate findings

60 Proprietary nutrient formula Proprietary nutrient formula containing 36 separate constituents may reduce manic sx when taken with conventional mood stabilizers (Popper 2001; Kaplan 2001). Proprietary nutrient formula containing 36 separate constituents may reduce manic sx when taken with conventional mood stabilizers (Popper 2001; Kaplan 2001). Proposed mechanism: correction of metabolic errors that predispose individuals to become symptomatic when micronutrient dietary deficiencies (Kaplan 2001). Proposed mechanism: correction of metabolic errors that predispose individuals to become symptomatic when micronutrient dietary deficiencies (Kaplan 2001).

61 Proprietary nutrient formula First series took 32 capsules daily in four divided doses over 6 mos. 11 pts reduced mood stabilizers by half while improving clinically First series took 32 capsules daily in four divided doses over 6 mos. 11 pts reduced mood stabilizers by half while improving clinically Second series 13 out of 19 BD pts remained stable after discontinuing mood stabilizers (Simmons 2003) Second series 13 out of 19 BD pts remained stable after discontinuing mood stabilizers (Simmons 2003)

62 Proprietary nutrient formula Two PCRTs on-going in U.S. and Canada to determine most efficacious nutrients, simplify Rx and minimize AE risk Two PCRTs on-going in U.S. and Canada to determine most efficacious nutrients, simplify Rx and minimize AE risk Protocol starts with 6 capsules TID then 3 capsules TID after two months Protocol starts with 6 capsules TID then 3 capsules TID after two months

63 Proprietary multi-ingredient formulasafety concerns Micronutrient-medication interactions require gradual dose reductions (Popper 2001) Micronutrient-medication interactions require gradual dose reductions (Popper 2001) Lowering mood stabilizer doses too rapidly risks worsening while keeping medications at therapeutic doses may cause toxicity Lowering mood stabilizer doses too rapidly risks worsening while keeping medications at therapeutic doses may cause toxicity Large prospective studies needed to clarify whether formula is beneficial and safe alone or as augmentation therapy Large prospective studies needed to clarify whether formula is beneficial and safe alone or as augmentation therapy

64 Acupuncture 2 12-wk sham-controlled randomized trials on adjunctive acupuncture adjunctive to mood stabilizers for sx of depression (N=26) and hypomania (N=20) in outpts dx;d BD I & II (Dennegy et al. 2009) 2 12-wk sham-controlled randomized trials on adjunctive acupuncture adjunctive to mood stabilizers for sx of depression (N=26) and hypomania (N=20) in outpts dx;d BD I & II (Dennegy et al. 2009) Rx-arm received treatment at specific acupoints addressing target sx. Sham group received non-specific acupuncture Rx Rx-arm received treatment at specific acupoints addressing target sx. Sham group received non-specific acupuncture Rx RESULTS: all patients improved; greater improvement with targeted Rx for both phases RESULTS: all patients improved; greater improvement with targeted Rx for both phases Few transient negative side effects and no attrition related to acupuncture Few transient negative side effects and no attrition related to acupuncture

65 International Network of Integrative Mental Health www.INIMH.org Advance a global vision for an integrated whole person approach to mental health care through education, research, networking and advocacy Advance a global vision for an integrated whole person approach to mental health care through education, research, networking and advocacy Create community and opportunities for nurturing personal and professional connections Create community and opportunities for nurturing personal and professional connections Promote evidence-based conventional and CAM therapies for the betterment of mental healthcare Promote evidence-based conventional and CAM therapies for the betterment of mental healthcare Educate, support and inspire mental health professionals and trainees at all career levels in all world regions Educate, support and inspire mental health professionals and trainees at all career levels in all world regions Facilitate collaborative efforts between researchers and clinicians Facilitate collaborative efforts between researchers and clinicians

66 General resources My website: www.IntegrativeMentalHealth.net My website: www.IntegrativeMentalHealth.net www.IntegrativeMentalHealth.net Textbook of Integrative Mental Health Care, Lake, Thieme Medical Publishers, September, 2006 Textbook of Integrative Mental Health Care, Lake, Thieme Medical Publishers, September, 2006 A Clinical Manual of Complementary and Alternative Treatments in Mental Health, eds. Lake and Spiegel, American Psychiatric Press, Inc., January, 2007 A Clinical Manual of Complementary and Alternative Treatments in Mental Health, eds. Lake and Spiegel, American Psychiatric Press, Inc., January, 2007 Integrative Mental Health Care: A Therapists Handbook, Lake, Norton, 2009 Integrative Mental Health Care: A Therapists Handbook, Lake, Norton, 2009

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