NCT02666989

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 25, 2016

Last Update Submit

January 27, 2016

Conditions

Major Depressive Disorder

Keywords

DepressionPlaceboOpen-labelClinical practice

Outcome Measures

Primary Outcomes (1)

  • v. HAM-D-17 (Hamilton, 1960)

    8 weeks

Study Arms (2)

open placebo

ACTIVE COMPARATOR

8 weeks of open placebo treatment

Drug: placebo

waitlist group

NO INTERVENTION

4 weeks of waiting list followed by 4 weeks of open placebo treatment

Interventions

placeboDRUG

2 placebo pills twice a day

open placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

uri nitzan, MD

CONTACT

urini@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
psychiatrists

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Last Updated

January 28, 2016

Record last verified: 2016-01