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Treatment of Comorbid Depression and Substance Abuse in Young People

Primary Purpose

Depression, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
sertraline
Cognitive Behavioural Therapy
Sponsored by
Dan Lubman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ORYGEN Youth Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sertaline

Placebo

Arm Description

8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry

8 week course of placebo

Outcomes

Primary Outcome Measures

HAMD depression at 10 weeks, 20 weeks and 44 weeks
OTI TLFB substance use levels at same time points

Secondary Outcome Measures

MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
DAS self report dysfunctional attitudes at same time points
ATQ self report automatic thoughts at same time points
SDS self report severity of dependence at same time points
DUMM self report drug use motives at same time points
RTC self report readiness to change at same time points
CISS self report coping with stress at same time points
CGI severity of illness at same time points
SOFAS social and occupational functioning at same time points

Full Information

First Posted
October 2, 2005
Last Updated
June 24, 2015
Sponsor
Dan Lubman
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1. Study Identification

Unique Protocol Identification Number
NCT00232284
Brief Title
Treatment of Comorbid Depression and Substance Abuse in Young People
Official Title
An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Lubman

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertaline
Arm Type
Active Comparator
Arm Description
8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
8 week course of placebo
Intervention Type
Drug
Intervention Name(s)
sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Other Intervention Name(s)
CBT
Intervention Description
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
Primary Outcome Measure Information:
Title
HAMD depression at 10 weeks, 20 weeks and 44 weeks
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
OTI TLFB substance use levels at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Secondary Outcome Measure Information:
Title
MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
DAS self report dysfunctional attitudes at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
ATQ self report automatic thoughts at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
SDS self report severity of dependence at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
DUMM self report drug use motives at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
RTC self report readiness to change at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
CISS self report coping with stress at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
CGI severity of illness at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks
Title
SOFAS social and occupational functioning at same time points
Time Frame
10 weeks, 20 weeks and 44 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Lubman
Organizational Affiliation
ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
ORYGEN Youth Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

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Treatment of Comorbid Depression and Substance Abuse in Young People

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