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Open-label Placebo for Depression (OLP Trial)

N/A
Recruiting
Led By Olga Tymofiyeva, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

OLP Trial 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.

Who is the study for?
This trial is for English-speaking adolescents aged 13-18 with mild to moderate depression who are not currently on medication. They must be under the care of a mental health professional or doctor and willing to give informed consent, along with their guardian if necessary.Check my eligibility
What is being tested?
The study tests the effectiveness of open-label placebos (a 'fake' treatment that participants know doesn't contain active medication) in treating adolescent depression. It explores how positive expectations can activate certain brain networks related to emotion and stress regulation.See study design
What are the potential side effects?
Since this trial involves an open-label placebo, which contains no active medical ingredients, side effects are expected to be minimal or non-existent. However, individual reactions may vary.

OLP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2 weeks post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 weeks post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Reynolds Adolescent Depression Scale (RADS-2) Scores
The cerebral blood perfusion (CBP) in the anterior cingulate cortex (ACC)- striato - amygdalo - thalamic network
Secondary outcome measures
Change in functional connectivity of the ACC - striato - amygdalo - thalamic network
Change in structural connectivity of the ACC - striato - amygdalo - thalamic network

OLP Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Open Label Placebo Group with RationaleExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
In the control group, the participants will not be taking any placebos or undergoing any other study-related treatments.
Group III: Open Label Placebo Group without RationaleActive Control1 Intervention

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,520 Previous Clinical Trials
15,241,885 Total Patients Enrolled
71 Trials studying Depression
28,220 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

Media Library

Open Label Placebo without Rationale (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04201106 — N/A
Depression Research Study Groups: Control, Open Label Placebo Group with Rationale, Open Label Placebo Group without Rationale
Depression Clinical Trial 2023: Open Label Placebo without Rationale Highlights & Side Effects. Trial Name: NCT04201106 — N/A
Open Label Placebo without Rationale (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04201106 — N/A
~7 spots leftby Dec 2024
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