Intermittent Explosive DisorderPhase 2NCT00078754
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
A Phase 2 study testing Fluoxetine and Divalproex in people with Intermittent Explosive Disorder, run by University of Chicago at 1 site in United States.
Trial summary
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED). Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Intermittent Explosive Disorder
- What is being tested?
- Fluoxetine and Divalproex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Intermittent Explosive Disorder (IED)
- In good physical health
- Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
- Willing and able to comply with the study requirements
Who cannot join
- Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
- Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18
- Current alcohol or drug abuse or dependence
- Active medical conditions that will interfere with the study
- Thymoleptic or neuroleptic treatments
- Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.
Show all 10Show fewer
- Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents
- Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry
- Hypersensitivity to fluoxetine or divalproex
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoxetine and Divalproex: Treatment Correlates in IED
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Read the detailed description
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.
- Conditions
- Intermittent Explosive Disorder
- Being tested
- Fluoxetine, Divalproex, Placebo
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Fluoxetine capsules by mouth, up to 60 mg daily
DivalproexDrug
Divalproex ER capsules by mouth, up to 3000 mg daily
PlaceboDrug
Placebo capsules by mouth, up to 8 capsules daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will to receive treatment with fluoxetine for 12 weeks Receives: Drug: Fluoxetine |
| B | Experimental | Participants will to receive treatment with divalproex for 12 weeks Receives: Drug: Divalproex |
| C | Placebo comparator | Participants will to receive treatment with placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 12
Secondary outcomes (1)
OAS-M
Overt Aggression Scale Modified for Outpatient Use. Minimum value = 0 Maximum value = Infinity. Higher scores means worse outcome.
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2004 (estimated)
- Study startMay 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermittent Explosive DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Emil F. Coccaro, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078754
- Sponsor's protocol ID
- R01MH066984
- Other IDs
- R01MH066984, DATR A5-ETMA
- Status last verified
- Apr 2021
- First submitted
- 5 Mar 2004
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine and Divalproex: Treatment Correlates in IED
- ClinicalTrials.gov ID
- NCT00078754
- Acronym / sponsor ID
- R01MH066984
- Conditions
- Intermittent Explosive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Mar 2004 (estimated)
- Results
- Posted 31 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FluoxetineParticipants will to receive treatment with fluoxetine for 12 weeks |
| B | Experimental | Drug: DivalproexParticipants will to receive treatment with divalproex for 12 weeks |
| C | Placebo comparator | Drug: PlaceboParticipants will to receive treatment with placebo for 12 weeks |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of Intermittent Explosive Disorder (IED)
- In good physical health
- Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
- Willing and able to comply with the study requirements
Key exclusion criteria (10 listed)
- Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
- Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18
- Current alcohol or drug abuse or dependence
- Active medical conditions that will interfere with the study
- Thymoleptic or neuroleptic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineFluoxetine capsules by mouth, up to 60 mg daily | Drug | A |
| DivalproexDivalproex ER capsules by mouth, up to 3000 mg daily | Drug | B |
| PlaceboPlacebo capsules by mouth, up to 8 capsules daily | Drug | C |
Primary outcome
Overt Aggression Scale-Modified for Outpatient Use (OAS-M)
Time frame: Measured at Week 12
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.
1 secondary outcome
OAS-M
Time frame: Measured at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intermittent Explosive Disorder
RecruitingPhase 2
Inflammatory Challenge in Human Aggression.
Intermittent Explosive Disorder
RecruitingObservational study
LHC-CIDI-5 in Hong Kong
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 2
Neural Correlates During Alcohol Intoxication
Alcohol Use Disorder, Intermittent Explosive Disorder
RecruitingPhase 2
Pimavanserin and Aggression and Social Cognition.
Intermittent Explosive Disorder
RecruitingPhase 2
Effect of Nitrous Oxide on Aggression.
Intermittent Explosive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil F. Coccaro, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine and Divalproex in people with Intermittent Explosive Disorder, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overt Aggression Scale-Modified for Outpatient Use (OAS-M) (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.