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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR PROZAC

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Clinical Trials for Prozac

Trial ID Title Status Sponsor Phase Summary
NCT00005015 Treatment of Depression in Youth With Bipolar Disorders Terminated National Institute of Mental Health (NIMH) Phase 3 THIS STUDY HAS BEEN DISCONTINUED. The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
NCT00006204 Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine) Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.
NCT00006286 Treatment for Adolescents With Depression Study (TADS) Completed National Institute of Mental Health (NIMH) Phase 3 TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States. The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments? The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression. The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.
NCT00011765 Effect of Fluoxetine (Prozac) on Domestic Violence Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 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.
NCT00027378 Pharmacological Intervention Project (Fluoxetine) Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Prozac

Condition Name

Condition Name for Prozac
Intervention Trials
Depression 13
Major Depressive Disorder 6
Healthy 6
Bipolar Disorder 5
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Condition MeSH

Condition MeSH for Prozac
Intervention Trials
Depression 23
Depressive Disorder 19
Disease 16
Depressive Disorder, Major 10
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Clinical Trial Locations for Prozac

Trials by Country

Trials by Country for Prozac
Location Trials
United States 72
Canada 5
India 2
Brazil 2
China 1
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Trials by US State

Trials by US State for Prozac
Location Trials
Pennsylvania 9
New York 8
Maryland 6
Massachusetts 4
California 4
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Clinical Trial Progress for Prozac

Clinical Trial Phase

Clinical Trial Phase for Prozac
Clinical Trial Phase Trials
Phase 4 15
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Prozac
Clinical Trial Phase Trials
Completed 39
Recruiting 6
Not yet recruiting 3
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Clinical Trial Sponsors for Prozac

Sponsor Name

Sponsor Name for Prozac
Sponsor Trials
National Institute of Mental Health (NIMH) 14
University of Pittsburgh 4
New York State Psychiatric Institute 3
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Sponsor Type

Sponsor Type for Prozac
Sponsor Trials
Other 63
NIH 20
Industry 14
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