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NCT01569659 · ClinicalTrials.gov registry record · Phase 4
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
A Phase 4 study of Schizophrenia, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
- 2
- Study locations
NCT01569659: Completed Phase 4 study of Schizophrenia, sponsored by Northwestern University.
NCT01569659 is a Phase 4 study of Schizophrenia that has completed, run by Northwestern University. The registered enrollment target is 101 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01569659, a Phase 4 study of Schizophrenia, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
- 2
- Study locations
Study Summary
The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a standard dose of lurasidone in patients with treatment resistant schizophrenia or schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of positive symptoms and other components of psychopathology (negative symptoms, general psychopathology, anxiety, depression, cognitive function, global function, severity of illness and tolerability). Patients must qualify for treatment resistance after two or more antipsychotic drug trials to be included in this trial.
Primary Outcome
Specify Full Scale Name and Construct: Positive and Negative Symptom Scale (PANSS) Scale description: A 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. These 30 items are split into three categories (Positive, Negative and General Psychopathology symptoms of schizophrenia), and the information is used to evaluate the presence, absence and severity of
Conditions Studied
Interventions
- DRUG Lurasidone
Study Locations (2)
Illinois
- Northwestern University Department of Psychiatry and Behavioral Sciences - Chicago
- Northwestern University Psychiatric Clinical Research Program - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
What the finished NCT01569659 record still lists
NCT01569659 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Lurasidone is the first listed.
NCT01569659 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01569659 about?
NCT01569659 is a clinical study titled "High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia". The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a standard dose of lurasidone in patients with treatment resistant schizophrenia or schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of positive symptoms and other compo...
What is the current status of trial NCT01569659?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2011-10. Estimated completion is 2015-07.
What conditions does trial NCT01569659 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01569659?
The interventions under investigation include: Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01569659?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01569659 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
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 NCT01569659's enrollment target sits among peer trials
101 139th of 315 higher than 177 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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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