Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00011765
Other study ID # 010098
Secondary ID 01-AA-0098
Status Completed
Phase Phase 2
First received February 28, 2001
Last updated June 30, 2017
Start date February 22, 2001
Est. completion date February 26, 2007

Study information

Verified date June 2, 2010
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 26, 2007
Est. primary completion date February 26, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluoxetine


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Davis M, Rainnie D, Cassell M. Neurotransmission in the rat amygdala related to fear and anxiety. Trends Neurosci. 1994 May;17(5):208-14. Review. — View Citation

Goldberg WG, Tomlanovich MC. Domestic violence victims in the emergency department. New findings. JAMA. 1984 Jun 22-29;251(24):3259-64. — View Citation

Pitts FN Jr, McClure JN Jr. Lactate metabolism in anxiety neurosis. N Engl J Med. 1967 Dec 21;277(25):1329-36. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT03037749 - Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Active, not recruiting NCT00847548 - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting N/A
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT01621334 - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use Phase 1
Completed NCT00983593 - A Randomized Clinical Study of a Mind-Body Approach to Domestic Violence Offender Treatment N/A
Completed NCT01803932 - Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Not yet recruiting NCT03672942 - Communication Skills vs. Mindfulness for IPV N/A
Completed NCT03883932 - Fatherhood Focused Family Violence Education Program N/A
Completed NCT05129501 - The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children N/A
Enrolling by invitation NCT05139069 - Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women N/A
Recruiting NCT03198429 - Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence N/A
Completed NCT04125251 - Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building N/A
Active, not recruiting NCT03236948 - RCT of the Effectiveness of the WfWI Intervention in Afghanistan Phase 3
Completed NCT02258841 - Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence N/A
Completed NCT01958554 - Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence Phase 2
Completed NCT01688427 - Perinatal Nurse Home Visiting Enhanced With mHealth Technology N/A