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NCT01200901 · ClinicalTrials.gov registry record · Phase 4
Quetiapine in Melancholic Depression
A Phase 4 study of Healthy and Depression, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01200901: Completed Phase 4 study of Healthy and Depression, sponsored by University of Cincinnati.
NCT01200901 is a Phase 4 study of Healthy and Depression that has completed, run by University of Cincinnati. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200901, a Phase 4 study of Healthy and Depression, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that: 1. quetiapine XR treatment will be effective and safe for patients with major depression with melancholic features 2. successful treatment with quetiapine XR will be associated with normalization of limbic areas associated with increased salivary cortisol response to a stressful task as well as normalization on the emotional faces task differences in the melancholic group compared with healthy volunteers. 3. successful treatment with quetiapine XR will be associated with normalization of the salivary cortisol response to the stressful math task (i.e. there will be a diminished post-treatment mean AUC for cortisol secretion after the stress task compared to the pre-treatment AUC values in the patient group)
Primary Outcome
Patients with major depression (N=20) will be recruited for the 8-week clinical trial of quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be referred for an initial fMRI scanning session prior to the initiation of quetiapine XR. Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR therapy and then will be re-acquired at the final study visit at 8 weeks (the time of scheduled visits).
Conditions Studied
Interventions
- DRUG Quetiapine
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-09 |
| Phase | Phase 4 |
What the finished NCT01200901 record still lists
NCT01200901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Quetiapine is the first listed.
NCT01200901 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01200901 about?
NCT01200901 is a clinical study titled "Quetiapine in Melancholic Depression". In summary, the investigators propose to integrate fMRI assessments within a clinical trial of quetiapine XR in patients with melancholic depression in order to test the predictions that: 1. quetiapine XR treatment will be effective and safe for patients with major depression with melancholic featu...
What is the current status of trial NCT01200901?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2008-09. Estimated completion is 2012-09.
What conditions does trial NCT01200901 study?
This clinical trial studies the following conditions: Healthy, Depression.
What interventions are being tested in trial NCT01200901?
The interventions under investigation include: Quetiapine (DRUG).
Who is sponsoring clinical trial NCT01200901?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01200901 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT01200901's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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