DepressionPhase 2NCT00232284
Treatment of Comorbid Depression and Substance Abuse in Young People
A Phase 2 study testing sertraline and Cognitive Behavioural Therapy in people with Depression and Substance-Related Disorders, run by Dan Lubman at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 26 years
- Conditions the study is for
- Depression, Substance-Related Disorders
- What is being tested?
- sertraline and Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2004to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse
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.
Read the 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
- Conditions
- Depression, Substance-Related Disorders
- Being tested
- sertraline, Cognitive Behavioural Therapy
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloft
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry
Cognitive Behavioural TherapyBehavioural
Also called CBT
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
| Study group | Role | What they receive |
|---|---|---|
| Sertaline | Active comparator | 8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry Receives: Drug: sertraline; Behavioral: Cognitive Behavioural Therapy |
| Placebo | Placebo comparator | 8 week course of placebo Receives: Drug: sertraline; Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD depression at 10 weeks, 20 weeks and 44 weeks
Measured: 10 weeks, 20 weeks and 44 weeks
OTI TLFB substance use levels at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
Secondary outcomes (9)
MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
Measured: 10 weeks, 20 weeks and 44 weeks
DAS self report dysfunctional attitudes at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
ATQ self report automatic thoughts at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
SDS self report severity of dependence at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
DUMM self report drug use motives at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
RTC self report readiness to change at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
CISS self report coping with stress at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
CGI severity of illness at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
SOFAS social and occupational functioning at same time points
Measured: 10 weeks, 20 weeks and 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Lubman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Lubman, Melbourne Health
- Investigators
- Dan Lubman, Principal investigator, ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232284
- Sponsor's protocol ID
- MHREC 2004.030
- Status last verified
- Jun 2015
- First submitted
- 2 Oct 2005
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse
- ClinicalTrials.gov ID
- NCT00232284
- Acronym / sponsor ID
- MHREC 2004.030
- Conditions
- Depression, Substance-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dan LubmanUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertaline | Active comparator | Drug: sertraline, Behavioral: Cognitive Behavioural Therapy8 week course of sertraline 50-100mg for those who fail to respond to CBT within first 4 weeks of study entry |
| Placebo | Placebo comparator | Drug: sertraline, Behavioral: Cognitive Behavioural Therapy8 week course of placebo |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: ZoloftRCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry | Drug | Placebo, Sertaline |
| Cognitive Behavioural TherapyAlso: CBTAn integrated 10-week CBT program for depression/anxiety and comorbid substance use | Behavioural | Placebo, Sertaline |
Primary outcome
HAMD depression at 10 weeks, 20 weeks and 44 weeks
Time frame: 10 weeks, 20 weeks and 44 weeks
OTI TLFB substance use levels at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
9 secondary outcomes
MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
Time frame: 10 weeks, 20 weeks and 44 weeks
DAS self report dysfunctional attitudes at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
ATQ self report automatic thoughts at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
SDS self report severity of dependence at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
DUMM self report drug use motives at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
RTC self report readiness to change at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
CISS self report coping with stress at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
CGI severity of illness at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
SOFAS social and occupational functioning at same time points
Time frame: 10 weeks, 20 weeks and 44 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Lubman principal investigator
ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sertraline and Cognitive Behavioural Therapy in people with Depression and Substance-Related Disorders, run by Dan Lubman at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAMD depression at 10 weeks, 20 weeks and 44 weeks (time frame: 10 weeks, 20 weeks and 44 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.