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NCT00113295 · ClinicalTrials.gov registry record · Phase 4
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
A Phase 4 study of Anxiety Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT00113295: Completed Phase 4 study of Anxiety Disorder, sponsored by Massachusetts General Hospital.
NCT00113295 is a Phase 4 study of Anxiety Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 50 participants, below the 423-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113295, a Phase 4 study of Anxiety Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
Primary Outcome
Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint. The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Quetiapine
- DRUG Continued Paroxetine CR
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
What the finished NCT00113295 record still lists
NCT00113295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 423-participant average among 20 other Anxiety Disorder trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00113295 reports a single indexed study location in Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00113295 about?
NCT00113295 is a clinical study titled "Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder". The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
What is the current status of trial NCT00113295?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2004-02. Estimated completion is 2007-11.
What conditions does trial NCT00113295 study?
This clinical trial studies the following conditions: Anxiety Disorder.
What interventions are being tested in trial NCT00113295?
The interventions under investigation include: Placebo (DRUG), Quetiapine (DRUG), Continued Paroxetine CR (DRUG).
Who is sponsoring clinical trial NCT00113295?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113295 being conducted?
This trial has 2 study locations across Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety Disorder
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 NCT00113295's enrollment target sits among peer trials
50 10th of 20 higher than 10 of 20 other Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorder 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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