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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2017|
Active Comparator: open placebo
8 weeks of open placebo treatment
2 placebo pills twice a day
No Intervention: waitlist group
4 weeks of waiting list followed by 4 weeks of open placebo treatment
- v. HAM-D-17 (Hamilton, 1960) [ Time Frame: 8 weeks ]
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
|Contact: uri nitzan, MDemail@example.com|