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NCT01795547 · ClinicalTrials.gov registry record · Phase 3
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
NCT01795547: Completed Phase 3 study, sponsored by H. Lundbeck A/S.
NCT01795547 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 295 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01795547, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
Study Summary
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
Primary Outcome
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 po
Interventions
- DRUG Aripiprazole and aripiprazole once-monthly
- DRUG Paliperidone and paliperidone palmitate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01795547 record still lists
NCT01795547 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Aripiprazole and aripiprazole once-monthly is the first listed.
NCT01795547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01795547 about?
NCT01795547 is a clinical study titled "Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia". To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an e...
What is the current status of trial NCT01795547?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2013-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01795547?
The interventions under investigation include: Aripiprazole and aripiprazole once-monthly (DRUG), Paliperidone and paliperidone palmitate (DRUG).
Who is sponsoring clinical trial NCT01795547?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01795547's enrollment target sits among peer trials
295 1166th of 2000 higher than 835 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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