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Treatment of Comorbid Depression and Substance Abuse in Young People

This study is currently recruiting participants.
Verified by Melbourne Health, October 2005

Sponsored by: Melbourne Health
Information provided by: Melbourne Health
ClinicalTrials.gov Identifier: NCT00232284
  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 II

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse

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

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


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

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Substance-Related Disorders
Sertraline
Disorders of Environmental Origin
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on October 03, 2008




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