Personalized Indications for CBT and Antidepressants in Treating Depression (CANBIND6)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02752542|
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Persistent Depressive Disorder||Behavioral: Cognitive Behavioral Therapy Drug: Pharmacotherapy||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Personalized Indications for Cognitive Behavioural Therapy and Antidepressants in the Treatment of Major Depressive Disorder and Persistent Depressive Disorder|
|Actual Study Start Date :||October 31, 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Cognitive Behavioral Therapy
Behavioral: 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 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.
- Total score on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2-52 weeks ]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.
- Global-Clinical Impression scale (GCI) [ Time Frame: 2-52 weeks ]Secondary outcome measures will include clinician-administered Global-Clinical Impression scale (GCI) administered by the treating clinician every two weeks
- Quick Inventory of Depressive Symptoms (QIDS-SR) [ Time Frame: 2-52 weeks ]Secondary outcome measures will include the Quick Inventory of Depressive Symptoms (QIDS-SR) administered by the treating clinician every two weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752542
|Contact: Rudolf Uher, MD, PhDemail@example.com|
|Contact: Beth McDougall, MScfirstname.lastname@example.org|
|Canada, Nova Scotia|
|Nova Scotia Health Authority||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 2E2|
|Contact: Rudolf Uher, MD PhD email@example.com|
|Contact: Beth McDougall, MSc Beth.McDougall@nshealth.ca|
|Principal Investigator:||Rudolf Uher, MD, PhD||Nova Scotia Health Authority|