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Open-Label Placebo for the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT02666989
Recruitment Status : Unknown
Verified January 2016 by Ziv Carmel, Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ziv Carmel, Shalvata Mental Health Center

Study Description
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Brief Summary:

Open label placebo treatment has been tried for irritable bowel syndrome (Kaptchuk et al, 2010), where three weeks of open label placebo proved superior to a wait-listed control group. Another pilot study demonstrated efficacy in treating children suffering from ADHD with open label placebo treatment (Sandler & Bodfish, 2007). Recent work has shown that placebo openly given can have significant analgesic effects for acute migraines (Kam-Hansen et al, 2014) and for experimentally-induced pain (Schafer at al, 2015). A preliminary attempt to treat depression with open label placebo proved the feasibility of such a study, but was too small and brief for conclusive results (Kelley et al, 2012).

We provide here the protocol for a study to assess the effect of open label placebo treatment for depression.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: placebo Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: open placebo
8 weeks of open placebo treatment
 Drug: placebo
2 placebo pills twice a day
No Intervention: waitlist group
4 weeks of waiting list followed by 4 weeks of open placebo treatment


Outcome Measures
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Primary Outcome Measures :
  1. v. HAM-D-17 (Hamilton, 1960) [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. Major Depressive Episode according to DSM-V ii. Mild to Moderate depression (8>HAM-D-17 <24) iii. Receiving antidepressant medication with no change in medication in the last two weeks or not receiving antidepressants medication

Exclusion Criteria:

i. Psychotic depression ii. Agitated depression iii. Bipolar depression iv. Current suicidality or past suicide attempt v. Current drug or alcohol abuse vi. Psychotic disorder vii. Drug and/or alcohol abuse

Contacts and Locations
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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): NCT02666989


Contacts
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Contact: uri nitzan, MD urini@clalit.org.il

Sponsors and Collaborators
Shalvata Mental Health Center
More Information
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Responsible Party: Ziv Carmel, psychiatrists, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT02666989     History of Changes
Other Study ID Numbers: Yehuda04
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Ziv Carmel, Shalvata Mental Health Center:
Depression
Placebo
Open-label
Clinical practice
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders