Trial Outcomes & Findings for Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder (NCT NCT00194129)
NCT ID: NCT00194129
Last Updated: 2018-02-20
Results Overview
A relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
COMPLETED
PHASE3
31 participants
Up to 6 months
2018-02-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
Baseline characteristics by cohort
| Measure |
Lithium Plus Divalproex
n=15 Participants
|
Lithium Plus Placebo
n=16 Participants
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
40 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
38.4 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Illness Type
Bipolar I disorder
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Illness Type
Bipolar II disorder
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsA relapse is a return to either a depressive, manic, hypomanic or mixed episode after a period of not have any symptoms.
Outcome measures
| Measure |
Lithium Plus Divalproex
n=15 Participants
|
Lithium Plus Placebo
n=16 Participants
|
|---|---|---|
|
Time to Treatment for Emerging Symptoms of a Mood Relapse
|
17.8 weeks
Interval 12.8 to 27.6
|
15.9 weeks
Interval 11.0 to 22.9
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 6Population: 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.
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
Outcome measures
| Measure |
Lithium Plus Divalproex
n=19 Participants
|
Lithium Plus Placebo
|
|---|---|---|
|
Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: 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.
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
Outcome measures
| Measure |
Lithium Plus Divalproex
n=15 Participants
|
Lithium Plus Placebo
|
|---|---|---|
|
Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: 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.
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
Outcome measures
| Measure |
Lithium Plus Divalproex
n=9 Participants
|
Lithium Plus Placebo
|
|---|---|---|
|
Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex
|
7 Participants
|
—
|
Adverse Events
Lithium Plus Divalproex
Lithium Plus Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lithium Plus Divalproex
n=15 participants at risk
|
Lithium Plus Placebo
n=16 participants at risk
|
|---|---|---|
|
Nervous system disorders
Tremors
|
66.7%
10/15 • Number of events 10
|
62.5%
10/16 • Number of events 10
|
|
Renal and urinary disorders
Polyuria/Polydipsia
|
40.0%
6/15 • Number of events 6
|
31.2%
5/16 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 4
|
37.5%
6/16 • Number of events 6
|
|
General disorders
Weight Gain
|
13.3%
2/15 • Number of events 2
|
31.2%
5/16 • Number of events 5
|
|
General disorders
Fatigue
|
33.3%
5/15 • Number of events 5
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Alopecia
|
20.0%
3/15 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Dry Mouth
|
20.0%
3/15 • Number of events 3
|
0.00%
0/16
|
|
Social circumstances
Sexual Dysfunction
|
13.3%
2/15 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
|
Social circumstances
Cognitive Dysfunction
|
13.3%
2/15 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
|
Eye disorders
Blurred Vision
|
13.3%
2/15 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Increased Appetite
|
0.00%
0/15
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15
|
12.5%
2/16 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place