Treatment of Comorbid Depression and Substance Abuse in Young People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dan Lubman, Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232284
First received: October 2, 2005
Last updated: June 24, 2015
Last verified: June 2015
  Purpose

This study aims to treat young people with an adjunctive integrated cognitive behavioral therapy (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 Behavioural Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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:

Primary Outcome Measures:
  • HAMD depression at 10 weeks, 20 weeks and 44 weeks [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • OTI TLFB substance use levels at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • DAS self report dysfunctional attitudes at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • ATQ self report automatic thoughts at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • SDS self report severity of dependence at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • DUMM self report drug use motives at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • RTC self report readiness to change at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • CISS self report coping with stress at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • CGI severity of illness at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]
  • SOFAS social and occupational functioning at same time points [ Time Frame: 10 weeks, 20 weeks and 44 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sertaline
8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry
Drug: sertraline
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
Other Name: Zoloft
Behavioral: Cognitive Behavioural Therapy
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
Other Name: CBT
Placebo Comparator: Placebo
8 week course of placebo
Drug: sertraline
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
Other Name: Zoloft
Behavioral: Cognitive Behavioural Therapy
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
Other Name: CBT

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 selective serotonin reuptake inhibitors (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

Locations
Australia, Victoria
ORYGEN Youth Health
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Dan Lubman
Investigators
Principal Investigator: Dan Lubman ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
  More Information

No publications provided

Responsible Party: Dan Lubman, Dr Dan Lubman, Melbourne Health
ClinicalTrials.gov Identifier: NCT00232284     History of Changes
Other Study ID Numbers: MHREC 2004.030
Study First Received: October 2, 2005
Last Updated: June 24, 2015
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
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015