CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
fluoxetine (Prozac) +1 moredrug
Likely dose
Fluoxetine dose not specified; 12-week acute phase plus 9-month naturalistic follow-upAI-extracted
Key inclusion· 1
  • ✓Confirmed diagnosis of alcohol use disorder and major depressive disorder
Key exclusion· 6
  • ✕Bipolar disorder, schizoaffective disorder, or schizophrenia
  • ✕Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, or significant liver disease
  • ✕Antipsychotic or antidepressant medication use in the month prior to study entry
  • ✕Illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00027378
NCT00027378Phase 2Completed
CompareCT.gov

Pharmacological Intervention Project (Fluoxetine)

University of Pittsburgh·interventional·Posted Dec 5, 2001·Updated Jul 18, 2013

In Brief

A Phase 2 clinical trial evaluating fluoxetine (Prozac) and Placebo plus Treatment As Usual for Alcoholism and Depression. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism, Depression
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2001
Enrollment StartJul 1, 2001
Primary CompletionJun 1, 2007
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 24.6 years ago

Interventions

fluoxetine (Prozac)drug

fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up

Placebo plus Treatment As Usualdrug

placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up