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NCT02505477 · ClinicalTrials.gov registry record · Phase 4
Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine
A Phase 4 study of Schizophrenia and Cognitive Deficits, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT02505477: Completed Phase 4 study of Schizophrenia and Cognitive Deficits, sponsored by University of California, Los Angeles.
NCT02505477 is a Phase 4 study of Schizophrenia and Cognitive Deficits that has completed, run by University of California, Los Angeles. The registered enrollment target is 51 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02505477, a Phase 4 study of Schizophrenia and Cognitive Deficits, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to attempt to treat cognitive and negative symptoms of schizophrenia, with the nutritional supplement N-acetylcysteine (NAC). Schizophrenia is a chronic mental disorder that affects approximately 65 million people worldwide, and causes significant disability and suffering. Patients with schizophrenia often hear voices and have persecutory delusions. Though these are the most recognizable features of the illness, the deficits most closely linked to disability are known as cognitive deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental tasks that require focus and attention, and also include memory and verbal skills. Negative symptoms refer to a lack of interest in the world, and decreased social interactions. In our study, the investigators aim to improve these symptoms and deficits by targeting the glutamate system. Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at others. As well, free radicals surrounding glutamate receptors also interfere with their proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that may restore glutamate to its correct levels in the brain, and may also help protect the brain from antioxidant damage. In our study, patients with schizophrenia will be randomly assigned to receive either NAC or placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione, will be measured before and after treatment, using a neuroimaging technique known as magnetic resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during and after treatment. The investigators hypothesize that glutamate and glutathione will be normalized in patients' brains, and that their negative and cognitive symptoms will be improved, too.
Primary Outcome
Negative symptoms will be assessed with the PANSS and the CAINS
Conditions Studied
Interventions
- OTHER Treatment as Usual
- DRUG N-acetylcysteine
Study Locations (1)
California
- UCLA Semel Institute for Neuroscience and Human Behavior - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 4 |
What the finished NCT02505477 record still lists
NCT02505477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT02505477 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02505477 about?
NCT02505477 is a clinical study titled "Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine". The purpose of this study is to attempt to treat cognitive and negative symptoms of schizophrenia, with the nutritional supplement N-acetylcysteine (NAC). Schizophrenia is a chronic mental disorder that affects approximately 65 million people worldwide, and causes significant disability and sufferi...
What is the current status of trial NCT02505477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2017-02-06. Estimated completion is 2023-01-31.
What conditions does trial NCT02505477 study?
This clinical trial studies the following conditions: Schizophrenia, Cognitive Deficits, Schizophrenia; Negative Type.
What interventions are being tested in trial NCT02505477?
The interventions under investigation include: Treatment as Usual (OTHER), N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT02505477?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02505477 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02505477's enrollment target sits among peer trials
51 206th of 315 higher than 109 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.
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