Open Label Placebo Group with Rationale for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression
Eligibility
< 65
All Sexes
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Study Summary

This trial is testing whether non-deceptive placebos (open-label placebo, OLP) can help relieve symptoms of depression in adolescents. The investigators think that the mechanism by which OLP exerts its action in adolescent depression is by forming a positive expectation, which activates endogenous mu-opioid receptor (MOR)-mediated neurotransmission in a network of regions implicated in emotion, stress regulation, and the pathophysiology of MDD, namely, the anterior cingulate cortex (ACC) - striato - amygdalo - thalamic network.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: At Baseline

At Baseline
The cerebral blood perfusion (CBP) in the anterior cingulate cortex (ACC)- striato - amygdalo - thalamic network
Week 2
Change in Reynolds Adolescent Depression Scale (RADS-2) Scores
Week 2
Change in functional connectivity of the ACC - striato - amygdalo - thalamic network
Change in structural connectivity of the ACC - striato - amygdalo - thalamic network

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Open Label Placebo Group without Rationale
1 of 3
Control
1 of 3
Open Label Placebo Group with Rationale
1 of 3

Active Control

Experimental Treatment

60 Total Participants · 3 Treatment Groups

Primary Treatment: Open Label Placebo Group with Rationale · Has Placebo Group · N/A

Open Label Placebo Group with Rationale
Behavioral
Experimental Group · 1 Intervention: Open Label Placebo with Rationale · Intervention Types: Behavioral
Open Label Placebo Group without Rationale
Behavioral
ActiveComparator Group · 1 Intervention: Open Label Placebo without Rationale · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,266 Previous Clinical Trials
11,467,271 Total Patients Enrolled
60 Trials studying Depression
19,281 Patients Enrolled for Depression
Olga Tymofiyeva, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
241 Total Patients Enrolled
2 Trials studying Depression
220 Patients Enrolled for Depression

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.