Recruiting

CBT & Antidepressants

Sponsor:

Nova Scotia Health Authority

Code:

NCT02752542

Conditions

Major Depressive Disorder

Persistent Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Pharmacotherapy

Study Details

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

Study ID

NCT02752542

Start date

Oct 31, 2016

Status verified date

May, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psychotherapy

Cognitive Behavioral Therapy

experimental: Pharmacotherapy

Antidepressant medication

Interventions

Cognitive Behavioral Therapy

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.

Pharmacotherapy

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.

Primary outcome measure

  • Total score on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2-52 weeks ]

Central Contacts and Locations

Central contacts

Rudolf Uher, MD, PhD

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

Jill Cumby, RN

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

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Rudolf Uher, MD PhD

uher@dal.ca

Jill Cumby, RN

902-473-1782Jill.Cumby@nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

May 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-05-14.