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NCT01354132 · ClinicalTrials.gov registry record · Phase 2
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01354132: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT01354132 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354132, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance. Aims: Does add-on NAC treatment in early psychosis influence: * positive and negative symptoms * extrapyramidal side-effects of other medication * plasma concentration of glutathione * Mismatch Negativity, a physiological marker
Primary Outcome
Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week: RATING SCALE 1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6
Interventions
- DRUG Placebo
- DRUG n-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01354132 record still lists
NCT01354132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01354132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354132 about?
NCT01354132 is a clinical study titled "N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis". The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase...
What is the current status of trial NCT01354132?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01354132?
The interventions under investigation include: Placebo (DRUG), n-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT01354132?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354132's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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