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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01650740
First received: July 24, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Drug: Duloxetine
Drug: placebo
Other: Study visits only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • >= 50% improvement in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (MADRS Response) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MADRS remission [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Credibility and Expectancy Scale (CES) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label duloxetine
12 week treatment with duloxetine
Drug: Duloxetine
30 mg daily x 1 week followed by 60 mg daily
Other Name: cymbalta
Experimental: Open-label Placebo
4 weeks of open label placebo with option to continue or switch to duloxetine for remaining 8 weeks.
Drug: placebo
small placebo capsule (30 mg duloxetine equivalent) x 1 week followed by 60 mg equivalent capsule daily
Experimental: Supportive clinical management
4 weeks of supportive clinical management visits with option to continue or switch to duloxetine for remaining 8 weeks.
Other: Study visits only
Weekly visits x 4 weeks followed by visits every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650740

Contacts
Contact: Mark Sinyor, MD 4164804070 mark.sinyor@sunnybrook.ca
Contact: Ayal Schaffer, MD 4164804070 ayal.schaffer@sunnybrook.ca

Locations
Canada, Ontario
Sunnybook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Mark Sinyor         
Principal Investigator: Mark Sinyor, MD         
Sub-Investigator: Ayal Schaffer, MD         
Sub-Investigator: Anthony J Levitt, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01650740     History of Changes
Other Study ID Numbers: 081-2012
Study First Received: July 24, 2012
Last Updated: July 24, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014