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NCT02553161 · ClinicalTrials.gov registry record · NA
Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth
A NA study, sponsored by University of Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 214
- Enrollment target
NCT02553161: Completed NA study, sponsored by University of Cincinnati.
NCT02553161 is a NA study that has completed, run by University of Cincinnati. The registered enrollment target is 214 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02553161, a NA study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 214 participants
- Enrollment target
Study Summary
A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a MRI scan and then randomized to treatment. Following randomization, high-risk youth will have visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.
Primary Outcome
Study the neural mechanisms of antidepressant-related dysfunctional arousal by ensuring that the treatment assignment precedes the 4-week scan, and the 4-week scan precedes the assessment of highest arousal measured between 4 and 16 weeks.The change in amygdala hyperactivity from the baseline to 4-week scan will be treated as the outcome and the treatment status (MED vs. No MED) will be treated as the predictor variable. The primary outcome is the level of post-treatment arousal (highest after t
Interventions
- DRUG Escitalopram
- BEHAVIORAL Cognitive behavioral Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2015-12 |
| Est. Completion | 2022-12 |
| Phase | NA |
What the finished NCT02553161 record still lists
NCT02553161 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Escitalopram is the first listed.
NCT02553161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02553161 about?
NCT02553161 is a clinical study titled "Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth". A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a MRI scan and then randomized ...
What is the current status of trial NCT02553161?
This trial is currently completed. It is a NA study. The enrollment target is 214 participants. The study started on 2015-12. Estimated completion is 2022-12.
What interventions are being tested in trial NCT02553161?
The interventions under investigation include: Escitalopram (DRUG), Cognitive behavioral Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02553161?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02553161's enrollment target sits among peer trials
214 487th of 2000 higher than 1,513 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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