Lithium
Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.
Lithium CarbonateLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2018-02-20
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L.
Lithium CarbonateDivalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml.
Valproic Acid · DepakotePlacebo pills that looked exact to divaloproex were provided to subjects and take twice daily.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Lithium Plus Divalproex | 15 | 17.8 | 12.8 to 27.6 |
| Lithium Plus Placebo | 16 | 15.9 | 11.0 to 22.9 |
Population: 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.
Population: 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.
Eligibility
primary outcomes
Time frame: Up to 6 months
A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
secondary outcomes
Time frame: Up to 6 months
Time frame: Up to 6 months
Time frame: Baseline to Month 6
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
Time frame: Baseline to Month 6
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
Time frame: Baseline to Month 6
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
Publications
No exact PMID-linked public article is currently readable locally.
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
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Completers | 19 | 11 | - |
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
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Completers | 15 | 8 | - |
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
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Completers | 9 | 7 | - |
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.
| Milestone | Lithium Plus Divalproex | Lithium Plus Placebo |
|---|---|---|
| STARTED | 15 | 16 |
| COMPLETED | 5 | 3 |
| NOT COMPLETED | 10 | 13 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Tremors | Nervous system disorders | Lithium Plus Divalproex: 10 / 15 · Lithium Plus Placebo: 10 / 16 |
| Polyuria/Polydipsia | Renal and urinary disorders | Lithium Plus Divalproex: 6 / 15 · Lithium Plus Placebo: 5 / 16 |
| Diarrhea | Gastrointestinal disorders | Lithium Plus Divalproex: 4 / 15 · Lithium Plus Placebo: 6 / 16 |
| Weight Gain | General disorders | Lithium Plus Divalproex: 2 / 15 · Lithium Plus Placebo: 5 / 16 |
| Fatigue | General disorders | Lithium Plus Divalproex: 5 / 15 · Lithium Plus Placebo: 1 / 16 |
| Nausea | Gastrointestinal disorders | Lithium Plus Divalproex: 2 / 15 · Lithium Plus Placebo: 3 / 16 |
| Alopecia | General disorders | Lithium Plus Divalproex: 3 / 15 · Lithium Plus Placebo: 1 / 16 |
| Dry Mouth | General disorders | Lithium Plus Divalproex: 3 / 15 · Lithium Plus Placebo: 0 / 16 |
| Sexual Dysfunction | Social circumstances | Lithium Plus Divalproex: 2 / 15 · Lithium Plus Placebo: 2 / 16 |
| Cognitive Dysfunction | Social circumstances | Lithium Plus Divalproex: 2 / 15 · Lithium Plus Placebo: 2 / 16 |
| Blurred Vision | Eye disorders | Lithium Plus Divalproex: 2 / 15 · Lithium Plus Placebo: 1 / 16 |
| Increased Appetite | General disorders | Lithium Plus Divalproex: 0 / 15 · Lithium Plus Placebo: 2 / 16 |
| Acne | Skin and subcutaneous tissue disorders | Lithium Plus Divalproex: 0 / 15 · Lithium Plus Placebo: 2 / 16 |