Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Express Scripts
Colorcon
Mallinckrodt
Baxter

Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR PROZAC WEEKLY


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


505(b)(2) Clinical Trials for Prozac Weekly

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 Recruiting University of Maryland Early Phase 1 2017-12-19 (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.
OTC NCT03228732 ↗ The Effects of Fluoxetine and/or DHEA Recruiting University of Maryland, Baltimore Early Phase 1 2017-12-19 (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 Prozac Weekly

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005015 ↗ Treatment of Depression in Youth With Bipolar Disorders Terminated National Institute of Mental Health (NIMH) Phase 3 1969-12-31 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 2000-03-01 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 1998-09-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prozac Weekly

Condition Name

Condition Name for Prozac Weekly
Intervention Trials
Depression 23
Major Depressive Disorder 17
Healthy 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Prozac Weekly
Intervention Trials
Depression 56
Depressive Disorder 47
Disease 30
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Prozac Weekly

Trials by Country

Trials by Country for Prozac Weekly
Location Trials
United States 256
Canada 11
China 7
France 3
India 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Prozac Weekly
Location Trials
New York 20
Pennsylvania 16
California 15
Texas 14
Ohio 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Prozac Weekly

Clinical Trial Phase

Clinical Trial Phase for Prozac Weekly
Clinical Trial Phase Trials
Phase 4 27
Phase 3 20
Phase 2/Phase 3 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Prozac Weekly
Clinical Trial Phase Trials
Completed 80
Recruiting 10
Terminated 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Prozac Weekly

Sponsor Name

Sponsor Name for Prozac Weekly
Sponsor Trials
National Institute of Mental Health (NIMH) 24
University of Pittsburgh 6
Eli Lilly and Company 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Prozac Weekly
Sponsor Trials
Other 142
NIH 34
Industry 26
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.