Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000675628
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
21/10/2005
Date last updated
23/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Comorbid Depression and Substance Abuse in Young People
Scientific title
A cross-over study to evaluate the effects of a cognitive behavioural therapy (CBT) intervention, followed by a randomised trial of sertraline/placebo (for non-responders to CBT only) in the treatment of comorbid depression and substance misuse to improve outcome in depression and substance use levels.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comorbidity of depression and substance use issues 823 0
Condition category
Condition code
Mental Health 887 887 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a naturalistic, prospective study of a targeted two-stage intervention, comprising a 10-session Cognitive Behaviour Therapy (CBT) intervention and a randomised 10-week double-blind, placebo-controlled trial of sertraline for partial and non-responders to the CBT intervention at week 6.
Intervention code [1] 671 0
Treatment: Other
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1150 0
Efficacy measures: symptomatic improvement measured in change scores. Self-report ratings of depression and substance use and clinician-rated measures of depression, substance use and functioning will be collected, and participants will be asked to provide several urine drug tests.
Timepoint [1] 1150 0
Assessed at baseline and followed up at weeks 16, 42, 68 and 120.
Secondary outcome [1] 2115 0
In addition, biological outcome and safety measures including vital signs, weight and routine clinical bloods will be reviewed from the clinical notes. For participants who consent to the genetic study, blood will be taken and assayed for the serotonin metabolite 5-hydroxyindoleacetic acid (5-HIAA). DNA will be extracted from the buffy coat of these samples and sent to the Australian Genome Research Facility for genotyping of the 5-HTTLPR alleles.
Timepoint [1] 2115 0

Eligibility
Key inclusion criteria
All patients with acute major depressive episode (more than one month) and 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 Patients must speak English as their preferred language, and have an estimated IQ >80.
Minimum age
16 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or past history of psychosis, significant head injury, seizures, neurological disease, impaired thyroid function, and steroid use; history or current evidence of any other significant clinical condition; participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study; treatment with an antidepressant within past 30 days; pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Medication component: numbered containers (provided by clinical trials pharmacy of the Royal Melbourne Hospital)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 980 0
Commercial sector/Industry
Name [1] 980 0
Pfizer
Country [1] 980 0
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 845 0
None
Name [1] 845 0
-
Address [1] 845 0
Country [1] 845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2289 0
Orygen Youth Health (NW Mental Health Program)
Ethics committee address [1] 2289 0
Ethics committee country [1] 2289 0
Australia
Date submitted for ethics approval [1] 2289 0
Approval date [1] 2289 0
Ethics approval number [1] 2289 0

Summary
Brief summary
This study 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. 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. The relationship between genetic variants of the 5-HTT and treatment response to both the CBT arm and SSRI treatment will also be explored.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35244 0
Address 35244 0
Country 35244 0
Phone 35244 0
Fax 35244 0
Email 35244 0
Contact person for public queries
Name 9860 0
Dr Leanne Hides
Address 9860 0
ORYGEN Youth Health
35 Poplar Road
Parkville VIC 3052
Country 9860 0
Australia
Phone 9860 0
+61 3 93422800
Fax 9860 0
Email 9860 0
leanne.hides@mh.org.au
Contact person for scientific queries
Name 788 0
Dr Dan Lubman
Address 788 0
ORYGEN Youth Health
35 Poplar Road
Parkville VIC 3052
Country 788 0
Australia
Phone 788 0
+61 3 93422800
Fax 788 0
Email 788 0
dan.lubman@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.