Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT01650740 |
Recruitment Status :
Terminated
(Poor recruitment results.)
First Posted : July 26, 2012
Last Update Posted : December 23, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Duloxetine Drug: placebo Other: Study visits only | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Open-label duloxetine
12 week treatment with duloxetine
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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.
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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.
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Other: Study visits only
Weekly visits x 4 weeks followed by visits every 2 weeks |
- >= 50% improvement in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (MADRS Response) [ Time Frame: 12 weeks ]
- MADRS remission [ Time Frame: 12 weeks ]
- Credibility and Expectancy Scale (CES) [ Time Frame: Baseline ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01650740
Canada, Ontario | |
Sunnybook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 |
Responsible Party: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01650740 |
Other Study ID Numbers: |
081-2012 |
First Posted: | July 26, 2012 Key Record Dates |
Last Update Posted: | December 23, 2014 |
Last Verified: | December 2014 |
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |