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:
- 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
- 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
- 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.
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.
- 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.
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
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).