Trial Outcomes & Findings for Treatment of Mania Symptoms With Drug Therapy (NCT NCT00183443)
NCT ID: NCT00183443
Last Updated: 2018-07-17
Results Overview
Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
Week 12
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
DVP + Placebo
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
25
|
|
Overall Study
COMPLETED
|
24
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Mania Symptoms With Drug Therapy
Baseline characteristics by cohort
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Mean Number of Lifetime Episodes of Depression
|
3.4 episodes of depression
STANDARD_DEVIATION 1.0 • n=5 Participants
|
3.5 episodes of depression
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.7 episodes of depression
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.5 episodes of depression
STANDARD_DEVIATION 1.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms.
Outcome measures
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Symptoms of Mania, as Measured by Young Mania Rating Scale
|
5.7 units on a scale
Standard Deviation 5.5
|
11.1 units on a scale
Standard Deviation 7.8
|
10.0 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Week 12The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The 17-item Likert-type scale (range 0-50) includes eight questions with a 5-point scale (ranging from 0=not present to 4=severe) and nine items scored from 0 to 2. Higher scores indicate increased depression severity. The total sum of these 17 answers is used to arrive at the final score: normal (0-7), mild (8-13), moderate (14-18), severe (19-22), or very severe (\>=23).
Outcome measures
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D,17)
|
13.2 units on a scale
Standard Deviation 11.6
|
18.3 units on a scale
Standard Deviation 9.2
|
18.8 units on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Week 12The Clinical Global Impression (CGI) rating scale was modified by Spearing and colleagues (1997) for use in bipolar disorder. CGI scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The revised CGI-Bipolar Version (CGI-BP) is effective in rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The CGI-BP is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal, not ill) to 7 (very severely ill). Each component of the CGI is rated separately; the instrument does not yield a global score. Only severity of illness scores are reported. Increased scores represent increased illness severity
Outcome measures
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)
|
1.58 units on a scale
Standard Deviation 1.02
|
2.54 units on a scale
Standard Deviation 1.33
|
2.32 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Week 12The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Outcome measures
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Global Assessment of Functioning
|
68.3 units on a scale
Standard Deviation 13.4
|
62.3 units on a scale
Standard Deviation 11.1
|
60.8 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Week 12The Social and Occupational Functioning Assessment Scale (SOFAS) provides a rating of global social and occupational function independent of clinical symptoms. SOFAS is provided in the Diagnostic and Statistical Manual (DSM-IV) as an Axis V measure. The SOFAS is a global rating of current functioning, which is scored positively on a scale from 0 to 100. Higher scores represent higher levels of functioning. This instrument is a one-item rating of consumer functioning.
Outcome measures
| Measure |
DVP + Placebo
n=24 Participants
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 Participants
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 Participants
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Social and Occupational Functioning Assessment Scale (SOFAS)
|
68.2 units on a scale
Standard Deviation 13.7
|
62.1 units on a scale
Standard Deviation 11.9
|
59.8 units on a scale
Standard Deviation 11.8
|
Adverse Events
DVP + Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
DVP + Quetiapine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DVP + Lithium
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DVP + Placebo
n=24 participants at risk
Participants will receive divalproex ER at a therapeutic dose, plus placebo
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
|
DVP + Quetiapine
n=26 participants at risk
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Quetiapine: Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
|
DVP + Lithium
n=25 participants at risk
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Lithium: Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Increased Appetite
|
29.2%
7/24 • Number of events 11
|
3.8%
1/26 • Number of events 12
|
4.0%
1/25 • Number of events 12
|
|
General disorders
Sedation
|
4.2%
1/24 • Number of events 9
|
3.8%
1/26 • Number of events 21
|
4.0%
1/25 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place