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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH066984 | U.S. NIH Grant/Contract | View source | |
| DATR A5-ETMA |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems.
Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Participants will to receive treatment with fluoxetine for 12 weeks |
|
| B | Experimental | Participants will to receive treatment with divalproex for 12 weeks |
|
| C | Placebo Comparator | Participants will to receive treatment with placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Fluoxetine capsules by mouth, up to 60 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overt Aggression Scale-Modified for Outpatient Use (OAS-M) | 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. | Measured at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| OAS-M | Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome. | Measured at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emil F. Coccaro, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - Fluoxetine Drug | Participants will to receive treatment with fluoxetine for 12 weeks Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily |
| FG001 | 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 |
| FG002 | Group C - Placebo | Participants will to receive treatment with placebo for 12 weeks Placebo: Placebo capsules by mouth, up to 8 capsules daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A - Fluoxetine Drug | Participants will to receive treatment with fluoxetine for 12 weeks Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily |
| BG001 | Group B - Divalproex Drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overt Aggression Scale-Modified for Outpatient Use (OAS-M) | 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. | Posted | Mean | Standard Error | units on a scale | Measured at Week 12 |
|
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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 | Group A - Fluoxetine Drug | Participants will to receive treatment with fluoxetine for 12 weeks Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyponatremia/hypokalemia | Blood and lymphatic system disorders | Systematic Assessment | lab results showed hyponatremia/hypokalemia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Investigations | Non-systematic Assessment |
Most participants did not have stable OAS-M Aggression scores from screening to randomization. Note that this was not a requirement for this study; only that OAS-Aggression scores were 15 or higher at screening.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emil F. Coccaro, MD | The University of Chicago | 773-834-4083 | ecoccaro@yoda.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
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| Divalproex |
| Drug |
Divalproex ER capsules by mouth, up to 3000 mg daily |
|
| Placebo | Drug | Placebo capsules by mouth, up to 8 capsules daily |
|
Participants will to receive treatment with divalproex for 12 weeks
Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily
| BG002 | Group C - Placebo | Participants will to receive treatment with placebo for 12 weeks Placebo: Placebo capsules by mouth, up to 8 capsules daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| overt aggression scale-modified (OAS-M). | OAS-M is a validated instrument that measures aggression. 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 more aggression. OAS-M score was calculated for the past week before the visit. | Mean | Standard Deviation | units on a scale |
|
| 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 |
| OG002 | Group C - Placebo | Participants will to receive treatment with placebo for 12 weeks Placebo: Placebo capsules by mouth, up to 8 capsules daily |
|
|
|
| Secondary | OAS-M | Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome. | OAS-M Scores in Placebo, Fluoxetine, Divalproex Arms as a function of LHA Score. | Posted | Mean | Standard Error | score on a scale | Measured at Week 12 |
|
|
|
|
| 1 |
| 29 |
| 23 |
| 29 |
| EG001 | 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 | 0 | 30 | 23 | 30 |
| EG002 | Group C - Placebo | Participants will to receive treatment with placebo for 12 weeks Placebo: Placebo capsules by mouth, up to 8 capsules daily | 0 | 31 | 24 | 31 |
|
| Trembling | Investigations | Non-systematic Assessment |
|
| Faintness or dizziness | Investigations | Non-systematic Assessment |
|
| Numbness or tingling in parts of your body | Investigations | Non-systematic Assessment |
|
| Feeling tense or keyed up | Investigations | Non-systematic Assessment |
|
| Nervousness or shakiness inside | Investigations | Non-systematic Assessment |
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| Soreness in your muscle, back, joints | Investigations | Non-systematic Assessment |
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| Spells of terror or panic | Investigations | Non-systematic Assessment |
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| Hot or cold spells | Investigations | Non-systematic Assessment |
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| Heart pounding or racing | Investigations | Non-systematic Assessment |
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| Pains in the heart or chest | Investigations | Non-systematic Assessment |
|
| Trouble getting your breath | Investigations | Non-systematic Assessment |
|
| Trouble remembering things | Investigations | Non-systematic Assessment |
|
| Feeling that familiar things are strange or unreal | Investigations | Non-systematic Assessment |
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| Nausea or upset stomach | Investigations | Non-systematic Assessment |
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| Drowsiness | Investigations | Non-systematic Assessment |
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| Dry mouth | Investigations | Non-systematic Assessment |
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| Blurred vision | Investigations | Non-systematic Assessment |
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| Increased salivation | Investigations | Non-systematic Assessment |
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| Sweating | Investigations | Non-systematic Assessment |
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| Diarrhea | Investigations | Non-systematic Assessment |
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| Difficulty urinating | Investigations | Non-systematic Assessment |
|
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| D014631 |
| Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Medium Aggression Group |
|
|
|
ANCOVA at endpoint with baseline OAS-M AGG score as covariate. |
| ANCOVA |
Baseline OAS-M Aggression score as covariate. |
| 0.80 |
| Mean Difference (Final Values) |
| 19.0 |
| Standard Error of the Mean |
| 2.7 |
| 2-Sided |
| Superiority |