Treatment of Comorbid Depression and Substance Abuse in Young People

Phase 4

Recruiting

• Conditions: Comorbidity of depression and substance use issues; Mental Health - Depression

• Registration Number: ACTRN12605000675628
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All patients with acute major depressive episode (more than one month) and concurrent DSM-IV substance abuse/dependence or the use of any illicit drug on a weekly basis in the month prior to referral, or alcohol consumption exceeding NHMRC guidelines Patients must speak English as their preferred language, and have an estimated IQ >80.

Exclusion Criteria

Current or past history of psychosis, significant head injury, seizures, neurological disease, impaired thyroid function, and steroid use; history or current evidence of any other significant clinical condition; participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study; treatment with an antidepressant within past 30 days; pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy measures: symptomatic improvement measured in change scores. Self-report ratings of depression and substance use and clinician-rated measures of depression, substance use and functioning will be collected, and participants will be asked to provide several urine drug tests.[Assessed at baseline and followed up at weeks 16, 42, 68 and 120. ]

Secondary Outcome Measures

Name	Time	Method
In addition, biological outcome and safety measures including vital signs, weight and routine clinical bloods will be reviewed from the clinical notes. For participants who consent to the genetic study, blood will be taken and assayed for the serotonin metabolite 5-hydroxyindoleacetic acid (5-HIAA). DNA will be extracted from the buffy coat of these samples and sent to the Australian Genome Research Facility for genotyping of the 5-HTTLPR alleles.[]