Domestic Violence Clinical Trial
Official title:
The Effect of Fluoxetine on Measures of Domestic Violence
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 spouse/significant
other in a small room, first discussing a neutral topic, such as the day's 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 participant's response to the drug.
Spouse/Significant other:
Spouses/significant 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.
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. ;
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