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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH050165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Abbott | INDUSTRY |
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This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients are initially stabilized on dual therapy of lithium and depakote and then randomly assigned to double-blind treatment with either lithium monotherapy or continued dual therapy. Patients remain in the study for six months or until they experience a relapse. Patients in this study are required to bring a friend or family member to all study visits as well as attend chemical dependency services. This study is sponsored by the NIMH. Subjects receive study-related care at no cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium plus Divalproex | Experimental | Patients assigned to the combination group were continued on lithium and blinded divalproex. |
|
| Lithium plus placebo | Placebo Comparator | Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment for Emerging Symptoms of a Mood Relapse | A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode | Up to 6 months | |
| Time to Treatment for Emerging Symptoms of a Depressive Episode | Up to 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R Calabrese, MD | Case Western Reserve University / University Hospitals of Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19192457 | Derived | Kemp DE, Gao K, Ganocy SJ, Elhaj O, Bilali SR, Conroy C, Findling RL, Calabrese JR. A 6-month, double-blind, maintenance trial of lithium monotherapy versus the combination of lithium and divalproex for rapid-cycling bipolar disorder and Co-occurring substance abuse or dependence. J Clin Psychiatry. 2009 Jan;70(1):113-21. doi: 10.4088/jcp.07m04022. Epub 2008 Dec 30. | |
| 18588360 | Derived | Gao K, Verduin ML, Kemp DE, Tolliver BK, Ganocy SJ, Elhaj O, Bilali S, Brady KT, Findling RL, Calabrese JR. Clinical correlates of patients with rapid-cycling bipolar disorder and a recent history of substance use disorder: a subtype comparison from baseline data of 2 randomized, placebo-controlled trials. J Clin Psychiatry. 2008 Jul;69(7):1057-63. doi: 10.4088/jcp.v69n0703. |
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Patients meeting stabilization criteria for a minimum of 4 consecutive weeks were eligible for random assignment to double-blind maintenance treatment. Patients not meeting these criteria by 24 weeks were discontinued from the study.
The study was conducted at the outpatient Mood Disorders Program of Case Western Reserve University/University Hospitals Case Medical Center between October 1997 and October 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithium Plus Divalproex | Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to divalproex arm, divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml. |
| FG001 | Lithium Plus Placebo | Participants were given lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. If randomized to placebo arm, placebo pills that looked exact to divaloproex were provided to subjects and take twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithium Plus Divalproex | |
| BG001 | Lithium Plus Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Treatment for Emerging Symptoms of a Mood Relapse | A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms. | Posted | Median | 95% Confidence Interval | weeks | Up to 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithium Plus Divalproex |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tremors | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kemp, MD | UHCMC Mood Disorders Program | 216-844-2865 | David.Kemp@UHhospitals.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D016651 | Lithium Carbonate |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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|
| Divalproex | Drug | Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml. |
|
|
| Placebo | Drug | Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily. |
|
| Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex |
Number of subjects who no longer met criteria for active abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex |
| Baseline to Month 6 |
| Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex | Number of subjects who no longer met criteria for active cannabis abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex | Baseline to Month 6 |
| Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex | Number of subjects who no longer met criteria for active cocaine abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex | Baseline to Month 6 |
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Illness Type | Bipolar I disorder involves periods of severe mood episodes from mania to depression. Bipolar II disorder is a milder form of mood elevation, involving milder episodes of hypomania that alternate with periods of severe depression. | Number | participants |
|
|
| Secondary | Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode | Due to the heavily censored nature of this data, the median survival for time to treatment for emerging manic/hypomanic/mixed symptoms in both arms is not evaluable. Statistics software was unable to analyze the data. | Posted | Up to 6 months |
|
|
| Secondary | Time to Treatment for Emerging Symptoms of a Depressive Episode | Due to the heavily censored nature of this data, the median survival for time to treatment for emerging depression symptoms in both arms is not evaluable. Statistics software was unable to analyze the data. | Posted | Up to 6 months |
|
|
| Secondary | Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex | Number of subjects who no longer met criteria for active abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex | This only includes subjects who had an alcohol use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of alcohol use disorders. | Posted | Count of Participants | Participants | Baseline to Month 6 |
|
|
|
| Secondary | Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex | Number of subjects who no longer met criteria for active cannabis abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex | This only includes subjects who had a cannabis use disorder at study entry. The purpose of this analysis was to see if treatment with both open-label lithium and divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cannabis use disorders. | Posted | Count of Participants | Participants | Baseline to Month 6 |
|
|
|
| Secondary | Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex | Number of subjects who no longer met criteria for active cocaine abuse or had entered into early full remission after receiving up to 6 months of open-label treatment with lithium and divalproex | This only includes subjects who were using cocaine at the time of study entry. The purpose of this analysis was to see if treatment with both open-label lithium & divalproex during the first phase of study participation (i.e. prior to randomization to lithium monotherapy or continued dual therapy) lead to a change in rates of cocaine use disorders. | Posted | Count of Participants | Participants | Baseline to Month 6 |
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| 0 |
| 15 |
| 13 |
| 15 |
| EG001 | Lithium Plus Placebo | 0 | 16 | 13 | 16 |
| Polyuria/Polydipsia | Renal and urinary disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight Gain | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Alopecia | General disorders | Non-systematic Assessment |
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| Dry Mouth | General disorders | Non-systematic Assessment |
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| Sexual Dysfunction | Social circumstances | Non-systematic Assessment |
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| Cognitive Dysfunction | Social circumstances | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | Non-systematic Assessment |
|
| Increased Appetite | General disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D008670 |
| Metals |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |