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	Treatment or Intervention	Phase
Domestic Violence	Drug: Fluoxetine	Phase II

Further Study Details: 

Expected Total Enrollment:  136

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 the SSRI, fluoxetine, or placebo. All participants will receive psychotherapy. All subjects 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.

Genders Eligible for Study:  Both

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 with 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).

Maryland
      National Institute on Alcohol Abuse and Alcoholism (NIAAA), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  010098; 01-AA-0098
Record last reviewed:  February 1, 2005
Last Updated:  February 24, 2005
Record first received:  February 28, 2001
ClinicalTrials.gov Identifier:  NCT00011765
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08