Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011765
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-02-28
Brief Title:
Effect of Fluoxetine Prozac on Domestic Violence
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effect of Fluoxetine on Measures of Domestic Violence
Status:
COMPLETED
Status Verified Date:
2010-06-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether fluoxetine Prozac used together with traditional psychotherapy can reduce aggression in people who are physically violent towards their spouses or significant others Treatment for domestic violence has centered on behavioral therapies such as anger management and self-control exercises Recent studies have shown that fluoxetine-a drug commonly used to treat depression and panic disorder-can decrease acts of aggression
Men and women between the ages of 18 and 65 who have a history of inflicting physical aggression on a spouses or significant others in the past year with at least one episode occurring not under the influence of alcohol may be eligible for this study Participants spouses or significant others will also be asked to participate All potential participants will be screened with a medical and psychiatric evaluation and history breath alcohol analysis blood tests urine drug screen and electrocardiogram
Those enrolled will undergo the following procedures
Perpetrator
Interview and questionnaires - Participants will be interviewed by a social worker about past and current mental health and use of alcohol and illicit drugs and will complete questionnaires assessing emotional state and personality depression anxiety aggression and alcohol consumption Some of the questionnaires will be repeated at monthly intervals
Physical performance testing - Performance and speed will be measured in three separate training sessions that involve repeatedly pressing a button on a button box console earning points worth money
Dyadic interaction paradigm - Participants will interact with their spousesignificant other in a small room first discussing a neutral topic such as the days events and then a subject that has been a source of conflict
Fluoxetine administration - Participants will be randomly assigned to receive either 10 mg of fluoxetine or placebo identical capsules with no active ingredients once a day for 3 days then twice a day increasing up to four capsules a day if there are no serious side effects Blood will be drawn once a month to measure drug levels At the end of 3 months participants taking placebo may remain in the study and receive fluoxetine
Clinic visits - Participants are followed in the clinic weekly for the first month then twice a month for the next 2 months for adjustment of number of pills evaluation of aggressive behavior and alcohol consumption and therapy for issues of self-esteem anger management and communication skills Couples therapy aimed at conflict resolution and improving communication skills will be offered
Genetic tests optional - Blood will be drawn to determine if there is a relationship between genes involved in a chemical process serotonin reuptake that is influenced by fluoxetine and the participants response to the drug
SpouseSignificant other
Spousessignificant others will complete several questionnaires once a month total 4 times to rate their partners behavior while in the study They will also participate in the dyadic interaction paradigm described above at the beginning and end of the study
Men and women between the ages of 18 and 65 who have a history of inflicting physical aggression on a spouses or significant others in the past year with at least one episode occurring not under the influence of alcohol may be eligible for this study Participants spouses or significant others will also be asked to participate All potential participants will be screened with a medical and psychiatric evaluation and history breath alcohol analysis blood tests urine drug screen and electrocardiogram
Those enrolled will undergo the following procedures
Perpetrator
Interview and questionnaires - Participants will be interviewed by a social worker about past and current mental health and use of alcohol and illicit drugs and will complete questionnaires assessing emotional state and personality depression anxiety aggression and alcohol consumption Some of the questionnaires will be repeated at monthly intervals
Physical performance testing - Performance and speed will be measured in three separate training sessions that involve repeatedly pressing a button on a button box console earning points worth money
Dyadic interaction paradigm - Participants will interact with their spousesignificant other in a small room first discussing a neutral topic such as the days events and then a subject that has been a source of conflict
Fluoxetine administration - Participants will be randomly assigned to receive either 10 mg of fluoxetine or placebo identical capsules with no active ingredients once a day for 3 days then twice a day increasing up to four capsules a day if there are no serious side effects Blood will be drawn once a month to measure drug levels At the end of 3 months participants taking placebo may remain in the study and receive fluoxetine
Clinic visits - Participants are followed in the clinic weekly for the first month then twice a month for the next 2 months for adjustment of number of pills evaluation of aggressive behavior and alcohol consumption and therapy for issues of self-esteem anger management and communication skills Couples therapy aimed at conflict resolution and improving communication skills will be offered
Genetic tests optional - Blood will be drawn to determine if there is a relationship between genes involved in a chemical process serotonin reuptake that is influenced by fluoxetine and the participants response to the drug
SpouseSignificant other
Spousessignificant others will complete several questionnaires once a month total 4 times to rate their partners behavior while in the study They will also participate in the dyadic interaction paradigm described above at the beginning and end of the study
Detailed Description:
There are no controlled studies assessing the effectiveness of pharmacological interventions to decrease aggression in perpetrators of domestic violence Since serotonin reuptake inhibitors SSRI have been shown to decrease aggression in other patient populations we will examine the effectiveness of SSRIs in reducing aggression in perpetrators of domestic violence In this protocol perpetrators of domestic violence will be randomized according to a double-blind design to receive either the SSRI fluoxetine or placebo All participants will receive psychotherapy All participants will also be carefully monitored in the outpatient clinic on a regular basis for three months Drug efficacy will be established using validated rating scales and provocative aggression inducing paradigms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-AA-0098 | None | None | None |