Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04201106 · ClinicalTrials.gov registry record · NA
A Neuroimaging Study of Open-label Placebo in Depressed Adolescents
A NA study of Depression, sponsored by University of California, San Francisco.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04201106: Active NA study of Depression, sponsored by University of California, San Francisco.
NCT04201106 is a NA study of Depression that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 16 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04201106, a NA study of Depression, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Major depressive disorder (MDD) is the current leading cause of disability worldwide and adolescence is an especially vulnerable period for the onset of depression. Non-pharmacologic approaches are particularly attractive as treatment of adolescent depression due to the elevated risks of side effects related to the use of psychotropic drugs during development. A recent meta-analysis detected a positive and significant effect of non-deceptive placebos (open-label placebo, OLP) for a series of clinical conditions, including adult depression. To the investigators' knowledge, no studies of OLP have been conducted in depressed adolescents to date, although placebo response rates in adolescent depression are especially high, accounting for over 80% of the actual response to antidepressant treatment. The study's main objective is to estimate the effectiveness and understand the mechanism of OLP in depressed adolescents. The central hypothesis is 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. The hypothesis has been formulated on the basis of published research and preliminary data. The investigators will test the hypothesis by performing structural and functional neuroimaging in 60 untreated 13-18 year-old adolescents with mild to moderate depression. The proposed research is significant, because it is expected to elucidate the mechanism of action of OLP and advance the understanding of the neural underpinnings of positive expectations in adolescent depression.
Primary Outcome
The investigators will be looking at changes in the RADS-2 scores scores. RADS-2 was selected as the primary clinical outcome measure because it is a widely used, well-established, and standardized self-report measure of adolescent depression. The RADS-2 has a possible range of 30 to 120. Higher scores represent higher levels of depression.
Conditions Studied
Interventions
- BEHAVIORAL Open Label Placebo with Rationale
- BEHAVIORAL Open Label Placebo without Rationale
Study Locations (1)
California
- UCSF - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-05-14 |
| Est. Completion | 2032-12-30 |
| Phase | NA |
What the registry record for NCT04201106 still lists
NCT04201106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Open Label Placebo with Rationale is the first listed.
NCT04201106 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04201106 about?
NCT04201106 is a clinical study titled "A Neuroimaging Study of Open-label Placebo in Depressed Adolescents". Major depressive disorder (MDD) is the current leading cause of disability worldwide and adolescence is an especially vulnerable period for the onset of depression. Non-pharmacologic approaches are particularly attractive as treatment of adolescent depression due to the elevated risks of side effect...
What is the current status of trial NCT04201106?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2020-05-14. Estimated completion is 2032-12-30.
What conditions does trial NCT04201106 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT04201106?
The interventions under investigation include: Open Label Placebo with Rationale (BEHAVIORAL), Open Label Placebo without Rationale (BEHAVIORAL).
Who is sponsoring clinical trial NCT04201106?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04201106 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04201106's enrollment target sits among peer trials
16 635th of 679 higher than 40 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Reaching Out to Distressed Medical Residents, Fellows and Faculty
RECRUITING · NA
-
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
RECRUITING · NA
-
Cold and Heat Investigation to Lower Levels of Depression
RECRUITING · NA
-
Dosing rTMS for Depression Post-SCI
RECRUITING · NA
-
Exploring Virtual Reality Adventure Training Exergaming
RECRUITING · NA
-
Brief Interventions for Coping with Distress
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy