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Last Updated: November 13, 2019

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CLINICAL TRIALS PROFILE FOR FLUOXETINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Fluoxetine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03228732 The Effects of Fluoxetine and/or DHEA Not yet recruiting University of Maryland Early Phase 1 2017-10-10 (1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluoxetine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000213 IV Cocaine Abuse: A Laboratory Model - 2 Completed Columbia University Phase 2 1990-04-01 The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
NCT00000213 IV Cocaine Abuse: A Laboratory Model - 2 Completed National Institute on Drug Abuse (NIDA) Phase 2 1990-04-01 The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
NCT00000213 IV Cocaine Abuse: A Laboratory Model - 2 Completed New York State Psychiatric Institute Phase 2 1990-04-01 The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
NCT00000373 Treatment of Obsessive-Compulsive Disorder Completed National Institute of Mental Health (NIMH) Phase 4 1992-09-01 The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000373 Treatment of Obsessive-Compulsive Disorder Completed University of Florida Phase 4 1992-09-01 The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000379 Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) Completed National Institute of Mental Health (NIMH) Phase 3 1999-01-01 The purpose of this study is to compare two treatments for post-traumatic stress disorder (PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing (EMDR, a psychological treatment in which the patient is led through the memory of a traumatic experience in order to heal him/herself). There are a variety of therapies used to treat PTSD, but the effectiveness of medication alone vs an exposure treatment, such as EMDR, has not been tested. Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will receive inactive placebo. Patients will then stop treatment and have evaluations, including psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months. An individual may be eligible for this study if he/she: Has PTSD and is 18 to 65 years old.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluoxetine Hydrochloride

Condition Name

Condition Name for Fluoxetine Hydrochloride
Intervention Trials
Depression 42
Major Depressive Disorder 37
Bipolar Disorder 10
Healthy 9
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Condition MeSH

Condition MeSH for Fluoxetine Hydrochloride
Intervention Trials
Depression 108
Depressive Disorder 92
Depressive Disorder, Major 61
Disease 45
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Clinical Trial Locations for Fluoxetine Hydrochloride

Trials by Country

Trials by Country for Fluoxetine Hydrochloride
Location Trials
United States 384
Canada 14
France 13
Mexico 9
Brazil 6
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Trials by US State

Trials by US State for Fluoxetine Hydrochloride
Location Trials
New York 42
California 26
Pennsylvania 21
Texas 20
Massachusetts 19
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Clinical Trial Progress for Fluoxetine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Fluoxetine Hydrochloride
Clinical Trial Phase Trials
Phase 4 71
Phase 3 40
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Fluoxetine Hydrochloride
Clinical Trial Phase Trials
Completed 139
Recruiting 35
Unknown status 15
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Clinical Trial Sponsors for Fluoxetine Hydrochloride

Sponsor Name

Sponsor Name for Fluoxetine Hydrochloride
Sponsor Trials
National Institute of Mental Health (NIMH) 39
Eli Lilly and Company 14
New York State Psychiatric Institute 12
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Sponsor Type

Sponsor Type for Fluoxetine Hydrochloride
Sponsor Trials
Other 281
Industry 72
NIH 59
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