Trial Outcomes & Findings for A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (NCT NCT00078754)
NCT ID: NCT00078754
Last Updated: 2021-04-27
Results Overview
OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Measured at Week 12
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Group A - Fluoxetine Drug
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group B - Divalproex Drug
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group C - Placebo
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
31
|
|
Overall Study
COMPLETED
|
14
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Baseline characteristics by cohort
| Measure |
Group B - Divalproex Drug
n=30 Participants
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group A - Fluoxetine Drug
n=29 Participants
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group C - Placebo
n=31 Participants
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=4 Participants
|
29 Participants
n=93 Participants
|
31 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=4 Participants
|
14 Participants
n=93 Participants
|
16 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=4 Participants
|
15 Participants
n=93 Participants
|
15 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
overt aggression scale-modified (OAS-M).
|
36.96 units on a scale
STANDARD_DEVIATION 26.42 • n=4 Participants
|
36.75 units on a scale
STANDARD_DEVIATION 46.88 • n=93 Participants
|
66.08 units on a scale
STANDARD_DEVIATION 77.99 • n=27 Participants
|
47.30 units on a scale
STANDARD_DEVIATION 56.68 • n=483 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 12OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.
Outcome measures
| Measure |
Group A - Fluoxetine Drug
n=14 Participants
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group B - Divalproex Drug
n=11 Participants
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group C - Placebo
n=16 Participants
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
|---|---|---|---|
|
Overt Aggression Scale-Modified for Outpatient Use (OAS-M)
|
7.86 units on a scale
Standard Error 4.11
|
15.73 units on a scale
Standard Error 10.15
|
8.88 units on a scale
Standard Error 3.51
|
SECONDARY outcome
Timeframe: Measured at Week 12Population: OAS-M Scores in Placebo, Fluoxetine, Divalproex Arms as a function of LHA Score.
Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome.
Outcome measures
| Measure |
Group A - Fluoxetine Drug
n=29 Participants
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group B - Divalproex Drug
n=30 Participants
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group C - Placebo
n=31 Participants
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
|---|---|---|---|
|
OAS-M
High Aggression Group
|
13.2 score on a scale
Standard Error 5.0
|
13.7 score on a scale
Standard Error 4.8
|
19.5 score on a scale
Standard Error 5.1
|
|
OAS-M
Medium Aggression Group
|
25.1 score on a scale
Standard Error 7.6
|
29.6 score on a scale
Standard Error 8.0
|
26.9 score on a scale
Standard Error 7.1
|
Adverse Events
Group A - Fluoxetine Drug
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Group B - Divalproex Drug
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Group C - Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Fluoxetine Drug
n=29 participants at risk
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group B - Divalproex Drug
n=30 participants at risk
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group C - Placebo
n=31 participants at risk
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
hyponatremia/hypokalemia
|
3.4%
1/29
|
0.00%
0/30
|
0.00%
0/31
|
Other adverse events
| Measure |
Group A - Fluoxetine Drug
n=29 participants at risk
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily
|
Group B - Divalproex Drug
n=30 participants at risk
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
|
Group C - Placebo
n=31 participants at risk
Participants will to receive treatment with placebo for 12 weeks
Placebo: Placebo capsules by mouth, up to 8 capsules daily
|
|---|---|---|---|
|
Investigations
Headaches
|
24.1%
7/29
|
20.0%
6/30
|
25.8%
8/31
|
|
Investigations
Trembling
|
6.9%
2/29
|
10.0%
3/30
|
3.2%
1/31
|
|
Investigations
Faintness or dizziness
|
6.9%
2/29
|
10.0%
3/30
|
12.9%
4/31
|
|
Investigations
Numbness or tingling in parts of your body
|
17.2%
5/29
|
13.3%
4/30
|
9.7%
3/31
|
|
Investigations
Feeling tense or keyed up
|
48.3%
14/29
|
36.7%
11/30
|
45.2%
14/31
|
|
Investigations
Nervousness or shakiness inside
|
20.7%
6/29
|
20.0%
6/30
|
12.9%
4/31
|
|
Investigations
Soreness in your muscle, back, joints
|
44.8%
13/29
|
56.7%
17/30
|
51.6%
16/31
|
|
Investigations
Spells of terror or panic
|
6.9%
2/29
|
10.0%
3/30
|
6.5%
2/31
|
|
Investigations
Hot or cold spells
|
10.3%
3/29
|
20.0%
6/30
|
12.9%
4/31
|
|
Investigations
Heart pounding or racing
|
20.7%
6/29
|
20.0%
6/30
|
16.1%
5/31
|
|
Investigations
Pains in the heart or chest
|
6.9%
2/29
|
13.3%
4/30
|
6.5%
2/31
|
|
Investigations
Trouble getting your breath
|
3.4%
1/29
|
20.0%
6/30
|
19.4%
6/31
|
|
Investigations
Trouble remembering things
|
31.0%
9/29
|
20.0%
6/30
|
22.6%
7/31
|
|
Investigations
Feeling that familiar things are strange or unreal
|
6.9%
2/29
|
13.3%
4/30
|
0.00%
0/31
|
|
Investigations
Nausea or upset stomach
|
17.2%
5/29
|
30.0%
9/30
|
29.0%
9/31
|
|
Investigations
Drowsiness
|
27.6%
8/29
|
40.0%
12/30
|
32.3%
10/31
|
|
Investigations
Dry mouth
|
17.2%
5/29
|
30.0%
9/30
|
12.9%
4/31
|
|
Investigations
Blurred vision
|
6.9%
2/29
|
6.7%
2/30
|
6.5%
2/31
|
|
Investigations
Increased salivation
|
3.4%
1/29
|
13.3%
4/30
|
6.5%
2/31
|
|
Investigations
Sweating
|
20.7%
6/29
|
30.0%
9/30
|
12.9%
4/31
|
|
Investigations
Diarrhea
|
6.9%
2/29
|
16.7%
5/30
|
16.1%
5/31
|
|
Investigations
Difficulty urinating
|
3.4%
1/29
|
3.3%
1/30
|
3.2%
1/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place