Phase 2
Completed N=50
Pharmacological Intervention Project (Fluoxetine)
Alcoholism · Depression
Source: ClinicalTrials.gov NCT00027378 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Alcohol Use Behaviors — 1.56; 1.73 standard drink (14 gr. alcohol) — p=.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Use Behaviors |
1.56; 1.73 | .05 |
| PRIMARY Depressive Symptoms |
6.79; 10.46 | — |
Eligibility Criteria
Inclusion Criteria
- Meets criteria for alcohol use disorder and major depressive disorder.
Exclusion Criteria
- Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.
- Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.
- Receiving antipsychotic or antidepressant medication in the month prior to entering the study.
- Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse).
- History of intravenous drug use.
- Pregnancy, inability or unwillingness to use contraceptive methods.
- Inability to read or understand study forms
- Less than 15 years of age or over 18 years of age will be excluded.
Data sourced from ClinicalTrials.gov (NCT00027378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.