Treatment of Comorbid Depression and Substance Abuse in Young People

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232284
First received: October 2, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

This study aims to treat young people with an adjunctive integrated CBT intervention and to examine the acceptability of this treatment approach within this population. 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.


Condition Intervention Phase
Depression
Substance-Related Disorders
Drug: sertraline
Behavioral: Cognitive-Behaviour Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Estimated Enrollment: 50
Study Start Date: September 2004
Estimated Study Completion Date: December 2006
Detailed Description:

The high prevalence of co-occurring depressive and substance use disorders amongst young people is especially problematic given the significant negative impact on both symptom course and outcome reported in adult samples. Whilst the clinical and functional outcomes in young people with comorbid disorders remains largely unknown, of particular concern is the consistent association between depression, substance misuse and suicidality in young people, especially given the high rates of youth suicide in Australia. As such, it is both a clinical priority and an important public health goal that the clinical characteristics and outcomes of young people with comorbid depression and substance abuse are identified, and that effective biopsychosocial interventions are developed that encompass predictors of treatment, such that targeted integrated treatments may be offered wherever affected young people present.

Whilst there is strong evidence for both SSRIs and CBT in the treatment of depression, and some support for their utility in alcohol dependence, no studies have examined their utility in a group of young people with comorbid depression and substance abuse. In fact, whilst CBT is suggested to be the first-line treatment for depression in young people, its role in comorbid disorders is less clear, and there is little data on predictors of treatment outcome in this population. Which young people best respond and which do not are important questions when designing the most appropriate interventions for real-world clinical settings. In this regard, the role of anti-depressants in comorbid populations also remains contentious, especially amongst those that fail or only partially respond to CBT. In particular, it is unclear at what stage anti-depressants should be offered or even whether SSRIs are indeed effective in this population.

Research Questions This project encompasses two complementary studies that aim to examine the characteristics and outcomes of young people with comorbid depression and substance abuse. Stage 1 is a preliminary naturalistic investigation of the characteristics of young people with comorbid depressive and substance use disorders presenting to drug treatment and mental health services, and describes their outcomes over 6, 12 and 24 months. This study seeks to explore what happens to these young people in the current service system, in terms of engagement and treatment, and related substance use and mental health outcomes. Stage 2 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. Stage 2 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 specific aims of the study are:

  • To describe the course of depressive disorders amongst young people with comorbid substance use disorders
  • To explore predictors of treatment response to an integrated CBT intervention
  • To explore the acceptability of the CBT intervention within a comorbid youth population
  • To explore the role of sertraline in the treatment of non-response to CBT in a comorbid youth population
  Eligibility

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16 and 26 years of age
  • acute major depressive episode (more than one month)
  • 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
  • English as their preferred language
  • estimated IQ >80

Exclusion Criteria:

  • Current or past history of psychosis
  • significant head injury
  • seizures
  • history or current evidence of any other significant clinical condition
  • treatment with an antidepressant within past 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232284

Contacts
Contact: Lisa Wong 93422800 lisa.wong@mh.org.au

Locations
Australia, Victoria
ORYGEN Youth Health Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Lisa Wong    93422800    lisa.wong@mh.org.au   
Contact: Leanne Hides, PhD (Clin)    93422800    leanne.hides@mh.org.au   
Principal Investigator: Dan Lubman         
Sub-Investigator: Leanne Hides         
Sub-Investigator: Nick Allen         
Sub-Investigator: Hok Pan Yuen         
Sub-Investigator: Gregor Berger         
Sub-Investigator: Patrick McGorry         
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Dan Lubman ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232284     History of Changes
Other Study ID Numbers: MHREC 2004.030
Study First Received: October 2, 2005
Last Updated: October 2, 2005
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Substance-Related Disorders
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014