NCT00232284

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

4.7 years

First QC Date

October 2, 2005

Last Update Submit

June 24, 2015

Conditions

DepressionSubstance-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • HAMD depression at 10 weeks, 20 weeks and 44 weeks

    10 weeks, 20 weeks and 44 weeks

  • OTI TLFB substance use levels at same time points

    10 weeks, 20 weeks and 44 weeks

Secondary Outcomes (9)

  • MASQ self report mood and anxiety at 10 weeks, 20 weeks and 44 weeks

    10 weeks, 20 weeks and 44 weeks

  • DAS self report dysfunctional attitudes at same time points

    10 weeks, 20 weeks and 44 weeks

  • ATQ self report automatic thoughts at same time points

    10 weeks, 20 weeks and 44 weeks

  • SDS self report severity of dependence at same time points

    10 weeks, 20 weeks and 44 weeks

  • DUMM self report drug use motives at same time points

    10 weeks, 20 weeks and 44 weeks

  • +4 more secondary outcomes

Study Arms (2)

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

Drug: sertralineBehavioral: Cognitive Behavioural Therapy

Placebo

PLACEBO COMPARATOR

8 week course of placebo

Drug: sertralineBehavioral: Cognitive Behavioural Therapy

Interventions

sertralineDRUG

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

Also known as: Zoloft
PlaceboSertaline
Cognitive Behavioural TherapyBEHAVIORAL

An integrated 10-week CBT program for depression/anxiety and comorbid substance use

Also known as: CBT
PlaceboSertaline

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORYGEN Youth Health

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

DepressionSubstance-Related Disorders

Interventions

SertralineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dan Lubman

    ORYGEN Youth Health, University of Melbourne, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Dan Lubman

Study Record Dates

First Submitted

October 2, 2005

First Posted

October 4, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

AU(1)