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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00232284




Registration number
NCT00232284
Ethics application status
Date submitted
2/10/2005
Date registered
4/10/2005
Date last updated
26/06/2015

Titles & IDs
Public title
Treatment of Comorbid Depression and Substance Abuse in Young People
Scientific title
An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse
Secondary ID [1] 0 0
MHREC 2004.030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Substance-Related Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sertraline
BEHAVIORAL - Cognitive Behavioural Therapy

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

Placebo comparator: Placebo - 8 week course of placebo


Treatment: Drugs: sertraline
RCT of sertraline/placebo for those young people who fail to respond within first 4 weeks of study entry

BEHAVIORAL: Cognitive Behavioural Therapy
An integrated 10-week CBT program for depression/anxiety and comorbid substance use
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HAMD depression at 10 weeks, 20 weeks and 44 weeks
Timepoint [1] 0 0
10 weeks, 20 weeks and 44 weeks
Primary outcome [2] 0 0
OTI TLFB substance use levels at same time points
Timepoint [2] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [1] 0 0
MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks
Timepoint [1] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [2] 0 0
DAS self report dysfunctional attitudes at same time points
Timepoint [2] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [3] 0 0
ATQ self report automatic thoughts at same time points
Timepoint [3] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [4] 0 0
SDS self report severity of dependence at same time points
Timepoint [4] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [5] 0 0
DUMM self report drug use motives at same time points
Timepoint [5] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [6] 0 0
RTC self report readiness to change at same time points
Timepoint [6] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [7] 0 0
CISS self report coping with stress at same time points
Timepoint [7] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [8] 0 0
CGI severity of illness at same time points
Timepoint [8] 0 0
10 weeks, 20 weeks and 44 weeks
Secondary outcome [9] 0 0
SOFAS social and occupational functioning at same time points
Timepoint [9] 0 0
10 weeks, 20 weeks and 44 weeks

Eligibility
Key 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
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
* history or current evidence of any other significant clinical condition
* treatment with an antidepressant within past 30 days

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ORYGEN Youth Health - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Dan Lubman
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00232284
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dan Lubman
Address 0 0
ORYGEN Youth Health, University of Melbourne, Department of Psychiatry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00232284