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NCT01136772 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Long-acting Injectable Medications for Schizophrenia
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 311
- Enrollment target
NCT01136772: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01136772 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 311 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136772, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 311 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).
Primary Outcome
Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
Interventions
- DRUG paliperidone palmitate
- DRUG haloperidol decanoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
What the finished NCT01136772 record still lists
NCT01136772 is an interventional study that assigns participants to a tested intervention. The registered 311 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which paliperidone palmitate is the first listed.
NCT01136772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136772 about?
NCT01136772 is a clinical study titled "A Comparison of Long-acting Injectable Medications for Schizophrenia". The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benef...
What is the current status of trial NCT01136772?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 311 participants. The study started on 2011-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01136772?
The interventions under investigation include: paliperidone palmitate (DRUG), haloperidol decanoate (DRUG).
Who is sponsoring clinical trial NCT01136772?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136772's enrollment target sits among peer trials
311 263rd of 2000 higher than 1,738 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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