Personalized Indications for CBT and Antidepressants in Treating Depression

NCT02752542 | Recruiting Phase 4

• 1 other identifier: 1021193
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Depression currently affects close to 2 million Canadians and is the leading cause of disability worldwide. Pharmacological treatments (antidepressant medication) and psychological treatments such as cognitive-behavioural therapy are available for depression, but the majority of those who receive treatment have an unsatisfactory response. On average, the combination of pharmacological and psychological treatment achieves better results than either treatment alone. However, the apparently superior results of combination treatment may be due to the fact that different individuals preferentially respond to pharmacological or psychological treatment. The invesitagtors have discovered several clinical factors and biomarkers that predict poor response to commonly used antidepressant medication: history of childhood maltreatment, loss of interest and reduced activity, a biomarker of systemic inflammation, and a genetic marker of sensitivity to environment. Indirect evidence suggests that the same factors may indicate the need for psychological treatment, but their usefulness as differential predictors of psychological and pharmacological treatment outcomes remains to be established. The investigators will test the hypothesis that a pre-determined clinical variables (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers (serum C-reactive protein, a marker of systemic inflammation, and insulin resistence, an indicator of metabolic health) differentially predict response to antidepressants and to cognitive-behavioural psychotherapy with clinically significant accuracy. If this hypothesis is supported, the resulting predictor will allow personalized selection of treatment for depression, leading to improved outcomes and healthcare efficiency. Additional objectives include replication of additional predictors and integrative analyses aimed at refining the treatment choice algorithms.

Conditions

Major Depressive Disorder; Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Total score on the Montgomery Asberg Depression Rating Scale (MADRS)

  Outcomes will be measured every 2 weeks during the 18 weeks trial and at medium-term follow ups 26 and 52 weeks after the start of treatment. The primary outcome measure will be the total score on MADRS, a valid and reliable measure, sensitive to change with treatment, with a strong internal consistency and scalability.

  2-52 weeks

Secondary Outcomes (2)

• Global-Clinical Impression scale (GCI)

  2-52 weeks

• Quick Inventory of Depressive Symptoms (QIDS-SR)

  2-52 weeks

Study Arms (2)

Psychotherapy

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Pharmacotherapy

EXPERIMENTAL

Antidepressant medication

Drug: Pharmacotherapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

CBT will be delivered in a one-to-one face-to-face format by trained Masters or PhD level CBT therapists who will follow a protocol adapted from existing manuals and piloted in the participating centres. Up to 20 sessions will be offered over 18 weeks, initially twice per week, then weekly and later spaced to every other week. The treatment will have core obligatory modules and flexible elements adaptable to participant's maintaining factors.

Psychotherapy

Pharmacotherapy DRUG

Pharmacotherapy will be prescribed and adjusted by psychiatrists in 20-30 minute pharmacotherapy sessions once every two weeks. The manual-guided best-evidence pharmacotherapy will follow current guidelines for first, second and third line treatment.41 The primary focus will be on serotonin-reuptake inhibiting antidepressant (escitalopram 5-20mg, sertraline 50-200 mg daily) monotherapy, which may remain the only treatment for the majority of participants. Augmentation (aripiprazole 2-10mg, bupropione 150-450mg) will be offered to participants with partial response. The manual, developed as part of Canadian Biomarker Integration Network in Depression (CAN-BIND).43, also specifies admissible supportive therapeutic elements and prohibits CBT-specific techniques.

Pharmacotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring clinical attention (judgement of intake clinician).
• a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
• a cumulative duration of depression of at least two months (this will exclude short-lasting first depressive episodes that do not require treatment of this intensity), age 18 or more (no upper limit)
• capacity to provide informed consent.

You may not qualify if:

• lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or current alcohol or drug use disorder
• pregnancy
• recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months)
• recently introduced antidepressant medication (new antidepressant in past 12 weeks or dose increase in the past 6 weeks)
• previous non-response to two or more of study medications
• acute suicide risk (MADRS suicide item≥4)
• current psychotic symptoms.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• University Health Network, Toronto: collaborator
• Queen's University: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Drug Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Rudolf Uher, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudolf Uher, MD, PhD

CONTACT

1-902-473-7209; rudolf.uher@nshealth.ca

Jill Cumby, RN

CONTACT

902-473-1782; jill.cumby@nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: October 31, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)