Domestic ViolencePhase 2NCT00011765
Effect of Fluoxetine (Prozac) on Domestic Violence
A Phase 2 study testing Fluoxetine in people with Domestic Violence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Fluoxetine
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2001to 26 Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Fluoxetine on Measures of Domestic Violence
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.
Read more
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.
Read the 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.
- Conditions
- Domestic Violence
- Being tested
- Fluoxetine
- Keywords
- Aggression, Serotonin Reuptake Inhibitors (SSRI), Rage, Fear, Violence, Domestic Violence, Physical Aggression, Serotonin Reuptake Inhibitor
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2001 (estimated)
- Study start22 Feb 2001
- Primary completion26 Feb 2007
- Study completion26 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011765
- Sponsor's protocol ID
- 010098
- Other IDs
- 01-AA-0098
- Status last verified
- 2 Jun 2010
- First submitted
- 28 Feb 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Goldberg WG, Tomlanovich MC. Domestic violence victims in the emergency department. New findings. JAMA. 1984 Jun 22-29;251(24):3259-64.
PubMed 6727000Davis M, Rainnie D, Cassell M. Neurotransmission in the rat amygdala related to fear and anxiety. Trends Neurosci. 1994 May;17(5):208-14. doi: 10.1016/0166-2236(94)90106-6.
PubMed 7520203Pitts FN Jr, McClure JN Jr. Lactate metabolism in anxiety neurosis. N Engl J Med. 1967 Dec 21;277(25):1329-36. doi: 10.1056/NEJM196712212772502. No abstract available.
PubMed 6081131Khalifa NR, Gibbon S, Vollm BA, Cheung NH, McCarthy L. Pharmacological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007667. doi: 10.1002/14651858.CD007667.pub3.
PubMed 32880105George DT, Phillips MJ, Lifshitz M, Lionetti TA, Spero DE, Ghassemzedeh N, Doty L, Umhau JC, Rawlings RR. Fluoxetine treatment of alcoholic perpetrators of domestic violence: a 12-week, double-blind, randomized, placebo-controlled intervention study. J Clin Psychiatry. 2011 Jan;72(1):60-5. doi: 10.4088/JCP.09m05256gry. Epub 2010 Jun 29.
PubMed 20673556
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluoxetine on Measures of Domestic Violence
- ClinicalTrials.gov ID
- NCT00011765
- Acronym / sponsor ID
- 010098
- Conditions
- Domestic Violence
- Keywords
- Aggression, Serotonin Reuptake Inhibitors (SSRI), Rage, Fear, Violence, Domestic Violence, Physical Aggression, Serotonin Reuptake Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 22 Feb 2001
- Primary completion
- 26 Feb 2007 (actual)
- Study completion
- 26 Feb 2007 (actual)
- First posted
- 1 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 6727000Goldberg WG, Tomlanovich MC. Domestic violence victims in the emergency department. New findings. JAMA. 1984 Jun 22-29;251(24):3259-64.
- Background: PubMed 7520203Davis M, Rainnie D, Cassell M. Neurotransmission in the rat amygdala related to fear and anxiety. Trends Neurosci. 1994 May;17(5):208-14. doi: 10.1016/0166-2236(94)90106-6.
- Background: PubMed 6081131Pitts FN Jr, McClure JN Jr. Lactate metabolism in anxiety neurosis. N Engl J Med. 1967 Dec 21;277(25):1329-36. doi: 10.1056/NEJM196712212772502. No abstract available.
- Derived from this study: PubMed 32880105Khalifa NR, Gibbon S, Vollm BA, Cheung NH, McCarthy L. Pharmacological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007667. doi: 10.1002/14651858.CD007667.pub3.
- Derived from this study: PubMed 20673556George DT, Phillips MJ, Lifshitz M, Lionetti TA, Spero DE, Ghassemzedeh N, Doty L, Umhau JC, Rawlings RR. Fluoxetine treatment of alcoholic perpetrators of domestic violence: a 12-week, double-blind, randomized, placebo-controlled intervention study. J Clin Psychiatry. 2011 Jan;72(1):60-5. doi: 10.4088/JCP.09m05256gry. Epub 2010 Jun 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine in people with Domestic Violence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00011765, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.