Depression Clinical Trial
Official title:
An Integrated Pharmacological and Psychological Approach to Young People With Comorbid Depression and Substance Abuse
Verified date | June 2015 |
Source | Melbourne Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 26 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | ORYGEN Youth Health | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Dan Lubman |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HAMD depression at 10 weeks, 20 weeks and 44 weeks | 10 weeks, 20 weeks and 44 weeks | No | |
Primary | OTI TLFB substance use levels at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | DAS self report dysfunctional attitudes at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | ATQ self report automatic thoughts at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | SDS self report severity of dependence at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | DUMM self report drug use motives at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | RTC self report readiness to change at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | CISS self report coping with stress at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | CGI severity of illness at same time points | 10 weeks, 20 weeks and 44 weeks | No | |
Secondary | SOFAS social and occupational functioning at same time points | 10 weeks, 20 weeks and 44 weeks | No |
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