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NCT01302964 · ClinicalTrials.gov registry record · Phase 3
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01302964: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT01302964 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302964, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
Primary Outcome
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatme
Interventions
- DRUG Placebo
- DRUG Mirtazapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-10-10 |
| Phase | Phase 3 |
What the finished NCT01302964 record still lists
NCT01302964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01302964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01302964 about?
NCT01302964 is a clinical study titled "Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders". This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
What is the current status of trial NCT01302964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2010-08. Estimated completion is 2017-10-10.
What interventions are being tested in trial NCT01302964?
The interventions under investigation include: Placebo (DRUG), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT01302964?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01302964's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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