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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 28, 2001 |
| Last Updated Date | August 24, 2009 |
| Start Date ICMJE | February 2001 |
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00011765 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Fluoxetine (Prozac) on Domestic Violence |
| Official Title ICMJE | The Effect of Fluoxetine on Measures of Domestic Violence |
| Brief 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
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| 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. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE | Domestic Violence |
| Intervention ICMJE | Drug: Fluoxetine |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 136 |
| Completion Date | February 2007 |
| Primary Completion Date | February 2007 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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). |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00011765 |
| Responsible Party | David T. George, M.D./National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health |
| Study ID Numbers ICMJE | 010098, 01-AA-0098 |
| Study Sponsor ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | February 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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