Effect of Fluoxetine (Prozac) on Domestic Violence

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00011765
First received: February 28, 2001
Last updated: June 4, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Domestic Violence
Drug: Fluoxetine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Effect of Fluoxetine on Measures of Domestic Violence

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 104
Study Start Date: February 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fluoxetine
    N/A
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Men and women over the age of 18 will be eligible for the study if they have:

A history of at least two episodes of physical aggression (i.e., hitting, pushing, punching, choking etc.) toward their spouse or significant other in the past year;

A history of at least one episode of physical aggression toward their spouse or significant other which occurred when the perpetrator had not used alcohol/drugs for at least a day;

A score of at least 3 on the Straus Conflict Tactics physical violence subscale;

A signed informed consent for participation in the protocol; and

Agreed to provide investigators with phone numbers of family and/or friends who will be able to provide information about the perpetrators' whereabouts in the event that the perpetrator does not come to appointments.

EXCLUSION CRITERIA:

Participants under the age of 18 will be excluded from the protocol because the generalizability of the results could potentially be compromised;

Abnormal laboratory or diagnostic tests which are judged to be clinically significant;

History of schizophrenia or bipolar disorder;

Participants judged to be a significant suicide/homicide risk;

Head trauma resulting in a period of unconsciousness lasting longer than one hour;

Documented seizure disorder (alcohol withdrawal seizures are not exclusionary);

History of a major medical problem (i.e., diabetes, cancer);

Women with a positive pregnancy test or women of childbearing age who are not willing to use some form of birth control during the study;

Participants whose spouse/significant other is pregnant;

Participants using an SSRI on a regular basis in the last three months;

Participants requiring other psychotropic medications;

Perpetrators requiring medications that inhibit CYP2D6, and could potentially interact with fluoxetine;

Individuals who are unwilling to forgo access to guns for the duration of the study;

Participants who are very controlling and are currently stalking their partner;

Participants who engage in forced sex;

Participants whose spouse/significant other feel that they are in great danger; and

Participants participating in the functional MRI paradigm will be excluded if they have ferromagnetic objects in their bodies which might be aversely affected by MRI (e.g., surgical clips; metal fragments in or near brain, eye, or blood vessels; cardiac or neurological pacemaker; cochlear or eye implant).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011765

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David T. George, M.D./National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00011765     History of Changes
Other Study ID Numbers: 010098, 01-AA-0098
Study First Received: February 28, 2001
Last Updated: June 4, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Aggression
Serotonin Reuptake Inhibitors (SSRI)
Rage
Fear
Violence
Domestic Violence
Physical Aggression
Serotonin Reuptake Inhibitor

Additional relevant MeSH terms:
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014