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Open-label Placebo for Depression (OLP Trial)
N/A
Recruiting
Led By Tony T Yang, MD, 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
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.
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Change in functional connectivity of the ACC - striato - amygdalo - thalamic network
Change in structural connectivity of the ACC - striato - amygdalo - thalamic network
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
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
674,911 Total Patients Enrolled
66 Trials studying Depression
33,510 Patients Enrolled for Depression
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,890 Total Patients Enrolled
73 Trials studying Depression
26,480 Patients Enrolled for Depression
Tony T Yang, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Depression
120 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a teenager between 13-18 years old, not taking any medication, and experiencing mild to moderate depression. A mental health professional or primary care doctor is aware of your condition.You have mental health conditions other than anxiety disorder, or have severe thoughts about hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Open Label Placebo Group with Rationale
- Group 3: Open Label Placebo Group without Rationale
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.