MedPath

Treatment Interrupts Depression Early

Phase 2
Recruiting
Conditions
Depression
Registration Number
NCT05002309
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

Inclusion Criteria:<br><br> - Age 12-25 years<br><br> - Diagnosis of major depressive disorder, onset of the major depressive disorder<br> within the last 12 months. Depression considered the most significant problem in<br> need of treatment.<br><br> - An additional inclusion criterion for entering Stage 1 (active intervention) is a<br> minimum moderate depression severity (CDRS-R=40; MADRS=20) that justifies the need<br> for treatment. Individuals who fulfill general inclusion criteria but are below the<br> depression severity threshold for active intervention will still be eligible to<br> participate in follow-up assessments.<br><br> - Verbal ability sufficient to participate in psychological treatment.<br><br>Exclusion Criteria:<br><br> - Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder,<br> pervasive developmental disorder or autism spectrum disorder, intellectual<br> disability, mental disorders secondary to neurological or other medical condition,<br> active substance use disorder.<br><br> - Previous trial of any treatment for major depressive disorder lasting 4 weeks or<br> longer, current use of antipsychotic, antidepressant or mood-stabilizer medication.<br><br> - Recent (past 6 weeks) change in any psychotropic medication (including stimulants,<br> hypnotics, anxiolytics) or receipt of 4 of more sessions of cognitive-behavioural<br> therapy.<br><br> - Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies<br> during the study, we will consult with Dr. Tanya Tulipan and jointly make the best<br> decision for the participant with the option to either continue or end study<br> treatment.<br><br> - No one will be excluded based on sex, gender, race, ethnicity, or living<br> arrangements.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of depressive symptoms;Severity of depressive symptoms;Proportion of time spent depression free
Secondary Outcome Measures
NameTimeMethod
Self-reported measure of depression.;Self-reported measure of generalized anxiety.;Self-reported measure of social anxiety.;Self-reported measures of general psychopathology.;Self-reported measure of quality of life.;Objective measures of psychopathology.;Objective measure of physical activity.;Objective measures of sleep.;Objective measures of educational progress.
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