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Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Duloxetine
placebo
Study visits only
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of written informed consent
  • Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
  • Both females and males, aged 18 to 65 years
  • Outpatient status
  • Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active
  • A grade 8 English comprehension, the ability to understand and comply with the requirements of the study and capable of providing informed consent
  • 17-item Hamilton Depression Rating Scale (HAM-D) score of 14-22 at screening and at baseline

Exclusion Criteria:

  • Diagnosis of a past hypomanic, manic or mixed state.
  • Current or past psychotic symptoms
  • Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
  • Any pervasive developmental disorder (according to DSM-IV criteria)
  • Diagnosis of dementia (according to DSM-IV criteria)
  • Is at significant risk for suicide, as defined by a score of ≥ 2 on the suicide item of the MADRS, any suicidal ideation with intent or a plan within the 3 months prior to study entry or in the opinion of the investigator.
  • Any history of lifetime suicide attempts
  • Current treatment with an antidepressant medication
  • Treatment with an antipsychotic, mood stabilizer or other psychoactive medication within a period of 5 half-lives of the medication prior to baseline visit
  • Known intolerance, hypersensitivity or lack of response to duloxetine as judged by the investigator
  • A history of treatment resistant depression (defined as 2 or more failed lifetime trials of antidepressant medication as judged by the investigator)
  • Currently undergoing psychotherapy that was initiated within the past 3 months
  • Significant medical condition that would contraindicate the use of duloxetine or that is untreated and would need urgent attention (as determined by treating physician)
  • Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of duloxetine
  • Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  • Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator
  • Pregnancy (or female of child-bearing age not using adequate contraception) or lactation
  • A positive β-hCG test at enrolment
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomisation of treatment in the present study
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

Sites / Locations

  • Sunnybook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Open-label duloxetine

Open-label Placebo

Supportive clinical management

Arm Description

12 week treatment with duloxetine

4 weeks of open label placebo with option to continue or switch to duloxetine for remaining 8 weeks.

4 weeks of supportive clinical management visits with option to continue or switch to duloxetine for remaining 8 weeks.

Outcomes

Primary Outcome Measures

>= 50% improvement in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (MADRS Response)

Secondary Outcome Measures

MADRS remission
Credibility and Expectancy Scale (CES)

Full Information

First Posted
July 24, 2012
Last Updated
December 19, 2014
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01650740
Brief Title
Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder
Official Title
A Randomized Trial of Sequenced Treatment Using Placebo Without Deception Followed by Open-Label Antidepressant Versus Immediate Open-Label Antidepressant Treatment for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment results.
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In recent years, there has been growing evidence that antidepressants are only marginally effective compared to placebo for mild to moderate depression. In other words, although many people improve when they take antidepressant medications, almost as many get better with placebo pills. One possible solution to this problem would be to give patients a trail of a placebo prior to giving them an antidepressant, however there are ethical issues with doing this deceptively. New evidence from other placebo-responsive disorders such as irritable bowel syndrome shows that people may benefit from placebos even if they know they are taking them. This study aims to determine whether giving placebos without deception to people with major depressive disorder followed by the option to switch to an antidepressant is an effective strategy. There will be 3 groups of subjects. The first group is a standard treatment arm and will receive duloxetine, an antidepressant. The second will be given a placebo with the option to switch to duloxetine if they do not improve. The third group will receive supportive clinical visits the option to switch to duloxetine if they do not improve. This design will allow us to determine whether a sequenced treatment of a placebo without deception and then the option to switch to an antidepressant is a viable strategy. It will also help us to determine to what degree the benefit comes from the ritual of receiving and taking the placebo tablet versus the benefit of visits with a doctor alone. The primary hypothesis is that there will be a less than 5% difference between response rates after 12 weeks in the sequenced placebo-then-antidepressant treatment group (both subjects who have remained on placebo as well as those who have switched to the antidepressant will be considered as one group) compared to the immediate antidepressant therapy group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label duloxetine
Arm Type
Experimental
Arm Description
12 week treatment with duloxetine
Arm Title
Open-label Placebo
Arm Type
Experimental
Arm Description
4 weeks of open label placebo with option to continue or switch to duloxetine for remaining 8 weeks.
Arm Title
Supportive clinical management
Arm Type
Experimental
Arm Description
4 weeks of supportive clinical management visits with option to continue or switch to duloxetine for remaining 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
cymbalta
Intervention Description
30 mg daily x 1 week followed by 60 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
small placebo capsule (30 mg duloxetine equivalent) x 1 week followed by 60 mg equivalent capsule daily
Intervention Type
Other
Intervention Name(s)
Study visits only
Intervention Description
Weekly visits x 4 weeks followed by visits every 2 weeks
Primary Outcome Measure Information:
Title
>= 50% improvement in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (MADRS Response)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
MADRS remission
Time Frame
12 weeks
Title
Credibility and Expectancy Scale (CES)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic criteria (confirmed using the MINI) Both females and males, aged 18 to 65 years Outpatient status Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active A grade 8 English comprehension, the ability to understand and comply with the requirements of the study and capable of providing informed consent 17-item Hamilton Depression Rating Scale (HAM-D) score of 14-22 at screening and at baseline Exclusion Criteria: Diagnosis of a past hypomanic, manic or mixed state. Current or past psychotic symptoms Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment Any pervasive developmental disorder (according to DSM-IV criteria) Diagnosis of dementia (according to DSM-IV criteria) Is at significant risk for suicide, as defined by a score of ≥ 2 on the suicide item of the MADRS, any suicidal ideation with intent or a plan within the 3 months prior to study entry or in the opinion of the investigator. Any history of lifetime suicide attempts Current treatment with an antidepressant medication Treatment with an antipsychotic, mood stabilizer or other psychoactive medication within a period of 5 half-lives of the medication prior to baseline visit Known intolerance, hypersensitivity or lack of response to duloxetine as judged by the investigator A history of treatment resistant depression (defined as 2 or more failed lifetime trials of antidepressant medication as judged by the investigator) Currently undergoing psychotherapy that was initiated within the past 3 months Significant medical condition that would contraindicate the use of duloxetine or that is untreated and would need urgent attention (as determined by treating physician) Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of duloxetine Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator Pregnancy (or female of child-bearing age not using adequate contraception) or lactation A positive β-hCG test at enrolment Involvement in the planning and conduct of the study Previous enrolment or randomisation of treatment in the present study Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
Facility Information:
Facility Name
Sunnybook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder

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