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NCT01339858 · ClinicalTrials.gov registry record · Phase 4
The Effect of N-Acetyl Cysteine on Cortical Erosion in Early Stage Schizophrenia
A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT01339858: Completed Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Indiana University.
NCT01339858 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that has completed, run by Indiana University. The registered enrollment target is 60 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339858, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is to determine if NAC, added to existing antipsychotic treatment, is superior to placebo for cortical erosion in patients with early stage psychosis. The primary hypothesis is that there will be significantly less cortical erosion as measured by cortical thickness, cortical volume and cortical white matter density (assessed by DTI) in patients treated for 12 months with NAC as compared to those treated with placebo. The secondary objectives of this study are to determine if 12 months of NAC add-on treatment is superior to placebo for fMRI determined working memory and semantic memory tasks, cortical MR spectroscopy measures (glutathione, N-acetylaspartate, and glutamine/glutamate levels), electrophysiologically determined attention measures (e.g., mismatch negativity, P300), symptoms, functional measures and cognitive functioning.
Primary Outcome
We anticipate that 12 months treatment with NAC as an add-on treatment will show significantly less cortical erosion as measured by cortical thickness than treatment with placebo
Conditions Studied
Interventions
- DRUG N-Acetyl Cysteine
- OTHER sugar pill
Study Locations (2)
Indiana
- Prevention and Recovery Center for Early Psychosis (PARC) - Indianapolis
- Indiana University Psychotic Disorders Clinic - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT01339858 record still lists
NCT01339858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (73% lower).
The record links to 4 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which N-Acetyl Cysteine is the first listed.
NCT01339858 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01339858 about?
NCT01339858 is a clinical study titled "The Effect of N-Acetyl Cysteine on Cortical Erosion in Early Stage Schizophrenia". The primary objective of this study is to determine if NAC, added to existing antipsychotic treatment, is superior to placebo for cortical erosion in patients with early stage psychosis. The primary hypothesis is that there will be significantly less cortical erosion as measured by cortical thicknes...
What is the current status of trial NCT01339858?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2011-05. Estimated completion is 2015-12.
What conditions does trial NCT01339858 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform, Psychotic Disorder NOS.
What interventions are being tested in trial NCT01339858?
The interventions under investigation include: N-Acetyl Cysteine (DRUG), sugar pill (OTHER).
Who is sponsoring clinical trial NCT01339858?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01339858 being conducted?
This trial has 2 study locations across Indiana. 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 NCT01339858's enrollment target sits among peer trials
60 188th of 315 higher than 119 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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