YoDA-C: Youth Depression Alleviation: A Randomised Controlled Trial of Cognitive Behavioural Therapy with Fluoxetine or Placebo (YoDA-C)
OrygenDataset description
Participants were aged 15-25 years with moderate to severe major depressive disorder. Participants were randomly assigned to receive cognitive behavioural therapy for 12 weeks, plus fluoxetine or placebo. Dataset includes demographic information, primary outcomes depression rating on the MADRS at baseline and 12 weeks, and other psychopathology information, including anxiety, substance use, suicidality, social and occupational functioning, quality of life, and satisfaction.Identifiers
Source Study
Trial name (public)
Youth Depression Alleviation: A Randomised Controlled Trial of Cognitive Behavioural Therapy with Fluoxetine or Placebo (YoDA-C)Trial acronym
YoDA-C
Trial ID
ACTRN12612001281886
Purpose
Treatment
Phase
Phase 3 / Phase 4
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Prof Christopher Davey
Brief Summary
The aim of this NHMRC-funded study is to answer an important question in the treatment of moderate-to-severe youth depression: should antidepressant treatment be started as a first-line treatment, concurrent with psychotherapy? The question has taken on increased clinical importance in the wake of recent evidence questioning the efficacy and safety of antidepressants in young people, and the subsequent development of treatment guidelines for youth depression that provide only qualified support f .... Read more
Key Inclusion Criteria
Aged between 15 and 25 years inclusive: Diagnosis of Major Depressive Disorder (MDD) using Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID); Score on the MADRS of 20 or greater, indicating depression of at least moderate severity; Ability to provide written informed consent
Key Exclusion Criteria
First episode psychosis (at least one positive symptom occurring daily for at least one week, or at least three times per week if the symptom lasts for longer than one hour on each occasion); Lifetime or current SCID-I diagnosis of bipolar I or II disorder; Acute or unstable medical disorder that would interfere with treatment; Severe disturbance such that the young person would be unable to comply with the requirements of informed consent or comply with the study protocol; Current treatment wit .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 153
Min. age 15 Years
Max. age 25 Years
Sex Both males and females
Condition category Depression
Condition code Mental Health
Intervention
Intervention code Behaviour , Treatment: Drugs
Cognitive Behavioural Therapy (CBT) will be administered once a week, over a period of 12 weeks Antidepressant fluoxetine hydrochloride or a placebo tablet will be administered in conjunction with CBT over a period of 12 weeks. The starting dose of fluoxetine or placebo will be 1 capsule or 20mg, administered orally. The dose may be increased at week 5 of the study to a maximum dose of 2 capsules or 40 mg. Each treatment session will last 45 to 50 minutes. Typically, an individual CBT session co .... Read more
Comparison
Control group Placebo
Placebo will be administered as a control treatment instead of fluoxetine. Placebo capsules will be made of Microcrystalline Cellulose and matched in appearance to the fluoxetine medication (all manufacturing will be conducted under Good Manufacturing Practice-GMP). It will be administered orally and in conjunction with CBT over a period of 12 weeks. The starting dose will be 1 capsule or 20mg of placebo, which may be increased at week 5 of the study to a maximum dose of 2 capsules or 40 mg of p .... Read more
Outcomes
Outcome: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 12Timepoint: week 12
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All individual participant data following de-identification.
When will data be available?
Data are available Immediately for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis