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NCT01392963 · ClinicalTrials.gov registry record · Phase 2
The Treatment of Depression With Botulinum Type A Toxin
A Phase 2 study, sponsored by Seton Healthcare Family.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01392963: Completed Phase 2 study, sponsored by Seton Healthcare Family.
NCT01392963 is a Phase 2 study that has completed, run by Seton Healthcare Family. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01392963, a Phase 2 study, has completed, sponsored by Seton Healthcare Family.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.
Primary Outcome
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6
Interventions
- DRUG Placebo
- DRUG botulinum toxin type A neurotoxin complex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01392963 record still lists
NCT01392963 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01392963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01392963 about?
NCT01392963 is a clinical study titled "The Treatment of Depression With Botulinum Type A Toxin". A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psyc...
What is the current status of trial NCT01392963?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-07. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01392963?
The interventions under investigation include: Placebo (DRUG), botulinum toxin type A neurotoxin complex (DRUG).
Who is sponsoring clinical trial NCT01392963?
This trial is sponsored by Seton Healthcare Family, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01392963's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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