MedPath

Personalized Indications for CBT and Antidepressants in Treating Depression

Phase 4
Recruiting
Conditions
Major Depressive Disorder
Persistent Depressive Disorder
Registration Number
NCT02752542
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
360
Inclusion Criteria

Inclusion Criteria:<br><br> - a diagnosis of MDD or PDD established with the Structured Clinical Interview for<br> DSM-5 (SCID-5), and depression being the primary problem requiring clinical<br> attention (judgement of intake clinician).<br><br> - a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression<br> (HRSD-17)<br><br> - a cumulative duration of depression of at least two months (this will exclude<br> short-lasting first depressive episodes that do not require treatment of this<br> intensity), age 18 or more (no upper limit)<br><br> - capacity to provide informed consent.<br><br>Exclusion Criteria<br><br> - lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder,<br> schizoaffective disorder, or current alcohol or drug use disorder<br><br> - pregnancy<br><br> - recent receipt of adequate trial of psychological treatment (10 or more sessions in<br> the past 12 months)<br><br> - recently introduced antidepressant medication (new antidepressant in past 12 weeks<br> or dose increase in the past 6 weeks)<br><br> - previous non-response to two or more of study medications<br><br> - acute suicide risk (MADRS suicide item=4)<br><br> - current psychotic symptoms.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total score on the Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measures
NameTimeMethod
Global-Clinical Impression scale (GCI);Quick Inventory of Depressive Symptoms (QIDS-SR)
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