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Personalized Indications for CBT and Antidepressants in Treating Depression (CANBIND6)

This study is currently recruiting participants.
Verified April 2017 by Rudolf Uher, Nova Scotia Health Authority
Sponsor:
ClinicalTrials.gov Identifier:
NCT02752542
First Posted: April 27, 2016
Last Update Posted: April 26, 2017
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.
Collaborators:
St. Joseph's Healthcare in Hamilton, Ontario
Queen's University
The Centre for Addiction and Mental Health in Toronto, Ontario.
Information provided by (Responsible Party):
Rudolf Uher, Nova Scotia Health Authority
  Purpose

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 Intervention Phase
Major Depressive Disorder Persistent Depressive Disorder Behavioral: Cognitive Behavioral Therapy Drug: Pharmacotherapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalized Indications for Cognitive Behavioural Therapy and Antidepressants in the Treatment of Major Depressive Disorder and Persistent Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Rudolf Uher, Nova Scotia Health Authority:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 360
Actual Study Start Date: October 31, 2016
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy
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.
Experimental: Pharmacotherapy
Antidepressant medication
Drug: 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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Rudolf Uher, MD, PhD 1-902-473-7209 rudolf.uher@nshealth.ca
Contact: Beth McDougall, MSc 902-473-5313 beth.mcdougall@nshealth.ca

Locations
Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Rudolf Uher, MD PhD       uher@dal.ca   
Contact: Beth McDougall, MSc       Beth.McDougall@nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
St. Joseph's Healthcare in Hamilton, Ontario
Queen's University
The Centre for Addiction and Mental Health in Toronto, Ontario.
Investigators
Principal Investigator: Rudolf Uher, MD, PhD Nova Scotia Health Authority
  More Information

Responsible Party: Rudolf Uher, Physician, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02752542     History of Changes
Other Study ID Numbers: 1021193
First Submitted: April 25, 2016
First Posted: April 27, 2016
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will not share any identifiable or anonymized data with parties other than the participating established academic institutions, which will sign a data transfer agreement (DTA) which will be created in collaboration with NSHA Research Services and subscribe to the code of ethics and confidential to rules commensurate with the TCPS2.

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs