Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149643
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2005-09-06
Brief Title:
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Fluoxetine for Major Depressive DisorderCannabis Disorder in Young People
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADY
Brief Summary:
Adolescents who are diagnosed with major depressive disorder are often also diagnosed with marijuana dependence Fluoxetine is an antidepressant medication currently used to treat young people who are diagnosed with major depressive disorder The purpose of this study is to determine the effectiveness of fluoxetine in treating adolescents and young adults diagnosed with both major depressive disorder and marijuana dependence
Detailed Description:
Marijuana dependence is the most common illicit substance use disorder in the United States Its prevalence is highest among adolescents and young adults Major depressive disorder is one of the most common conditions seen in marijuana dependent individuals Fluoxetine is an antidepressant medication for treatment of major depression among adolescents and children The purpose of this study is to determine the effectiveness of fluoxetine in treating adolescents and young people dually diagnosed with major depressive disorder and marijuana dependence
Participants in this 12-week trial will be randomly assigned to receive either fluoxetine or placebo Participants will initially be randomly assigned to receive either 10 mg of fluoxetine or placebo Medication will be given in the morning If no side effects are observed over the first two weeks of the study medication will be increased to a daily dose of 20 mg of fluoxetine or placebo If at Week 4 a participant continues to demonstrate significant depressive symptoms medication will be increased to 30 mg daily All participants will also receive Treatment as Usual TAU during the acute phase of the trial which will consist of motivation enhancement therapy MET and Cognitive Behavioral Therapy CBT Outcome measures will be obtained at screening baseline and weekly intervals for the first four weeks of the treatment phase they will then be obtained biweekly for the final 8 weeks of the treatment phase Blood will be drawn at baseline and at Weeks 4 8 and 12 to assess the level of three liver enzymes Gamma-glutamyl Transferase gGTP Aspartate aminotransferase SGOT and Alanine aminotransferase SGPT This will provide a biochemical monitoring of drinking behavior and medication compliance The 12-week acute phase study will be supplemented by a 9-month naturalistic follow-up phase during which care will be transferred from the study provider to the community provider The study will end with a 1-year follow-up evaluation
Participants in this 12-week trial will be randomly assigned to receive either fluoxetine or placebo Participants will initially be randomly assigned to receive either 10 mg of fluoxetine or placebo Medication will be given in the morning If no side effects are observed over the first two weeks of the study medication will be increased to a daily dose of 20 mg of fluoxetine or placebo If at Week 4 a participant continues to demonstrate significant depressive symptoms medication will be increased to 30 mg daily All participants will also receive Treatment as Usual TAU during the acute phase of the trial which will consist of motivation enhancement therapy MET and Cognitive Behavioral Therapy CBT Outcome measures will be obtained at screening baseline and weekly intervals for the first four weeks of the treatment phase they will then be obtained biweekly for the final 8 weeks of the treatment phase Blood will be drawn at baseline and at Weeks 4 8 and 12 to assess the level of three liver enzymes Gamma-glutamyl Transferase gGTP Aspartate aminotransferase SGOT and Alanine aminotransferase SGPT This will provide a biochemical monitoring of drinking behavior and medication compliance The 12-week acute phase study will be supplemented by a 9-month naturalistic follow-up phase during which care will be transferred from the study provider to the community provider The study will end with a 1-year follow-up evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA019142 |
| R01DA019142 | NIH | None | None |