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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 weeks post baseline

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,411 Total Patients Enrolled

71 Trials studying Depression

28,768 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to participate in this research endeavor?

"This medical trial is seeking to enrol 60 adolescents with depression between the ages of 13 and 18."

Answered by AI

Is this research open to individuals who are 35 years and older?

"According to the stated criteria for participation, eligible individuals must be aged between 13 and 18 years old. This study is one of 177 that include patients under eighteen and 849 studies involving people over 65."

Answered by AI

Are there any available spots for participation in this clinical research?

"According to clinicaltrials.gov, this medical research effort is actively searching for participants. The study was initially listed on May 14th 2020 and the most recent edit occurred on August 8th 2022."

Answered by AI

What is the total number of participants enrolled in this research project?

"Absolutely. According to the information provided on clinicaltrials.gov, this research project is actively seeking participants. Initially posted on May 14th 2020 and most recently updated on August 8th 2022, 60 individuals are being sought for enrollment across a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Neuroimaging Study of Open-label Placebo in Depressed Adolescents

2020. "A Neuroimaging Study of Open-label Placebo in Depressed Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201106.