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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04201106
The ClinicalTrials.gov registry entry for NCT04201106 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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