Personalized Indications for CBT and Antidepressants in Treating Depression

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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 set of clinical variables (history of childhood maltreatment, loss of interest and reduced activity) and biomarkers (serum C-reactive protein, a marker of systemic inflammation, and short alleles of the serotonin transporter gene promoter polymorphism) differentially predicts 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Collaborators: Centre for Addiction and Mental Health; Queen's University; St. Joseph's Healthcare in Hamilton, Ontario; The Centre for Addiction and Mental Health in Toronto, Ontario.; University Health Network, Toronto
• Treatments: Antidepressive Agents

Criteria

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.