RecruitingPhase 4NCT02752542

Personalized Indications for CBT and Antidepressants in Treating Depression

Personalized Indications for Cognitive Behavioural Therapy and Antidepressants in the Treatment of Major Depressive Disorder and Persistent Depressive Disorder

Sponsor

Nova Scotia Health Authority

Enrollment

80 participants

Start Date

Oct 31, 2016

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder Persistent Depressive Disorder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria7

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.

Interventions

BEHAVIORALCognitive 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.

DRUGPharmacotherapy

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.