Treatment of Comorbid Depression and Substance Abuse in Young People

A cross-over study to evaluate the effects of a cognitive behavioural therapy (CBT) intervention, followed by a randomised trial of sertraline/placebo (for non-responders to CBT only) in the treatment of comorbid depression and substance misuse to improve outcome in depression and substance use levels.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000675628

Enrollment

Registered

2005-10-21

Start date

2005-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to treat a sub-sample of these young people with an adjunctive integrated CBT intervention and to examine the acceptability of this treatment approach within this population. In addition, this study seeks to explore predictors of treatment outcome so as to inform the further development of this integrated intervention. The study will also include a pilot placebo-controlled trial of sertraline for those young people who fail to or only partially respond to the CBT intervention, so as to determine whether adjunctive anti-depressant treatment improves clinical response in this population. The relationship between genetic variants of the 5-HTT and treatment response to both the CBT arm and SSRI treatment will also be explored.

Interventions

This study is a naturalistic, prospective study of a targeted two-stage intervention, comprising a 10-session Cognitive Behaviour Therapy (CBT) intervention and a randomised 10-week double-blind, placebo-controlled trial of sertraline for partial and non-responders to the CBT intervention at week 6.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to 26 Years

Healthy volunteers

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.

Outcome results