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NCT01514682 · ClinicalTrials.gov registry record · NA
Anti-Inflammatory Treatment of Schizophrenia
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT01514682: Completed NA study, sponsored by University of Maryland, Baltimore.
NCT01514682 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01514682, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Despite current antipsychotic treatment, the majority of people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. An alternative approach to the use of psychotropic agents for the treatment of persistent symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state hypothesized to underlie the symptom and sign manifestations of the illness. The investigators primary hypothesis is that add-on anti-inflammatory combination therapy will have significant beneficial effects on persistent positive symptoms and cognitive impairments. The investigators secondary hypotheses are: 1. add-on anti-inflammatory combination therapy will be associated with improvements in depressive and negative symptoms and a reduction in pro-inflammatory cytokines 2. add-on anti-inflammatory combination therapy compared to placebo will not be associated with elevated adverse risk.
Primary Outcome
The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.
Interventions
- DRUG Placebo
- DRUG Anti-inflammatory Combination Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06 |
| Est. Completion | 2017-04-17 |
| Phase | NA |
What the finished NCT01514682 record still lists
NCT01514682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01514682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01514682 about?
NCT01514682 is a clinical study titled "Anti-Inflammatory Treatment of Schizophrenia". Despite current antipsychotic treatment, the majority of people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. An alternative approach to the use of psychotropic agents for the treatment of persistent symptoms is the use of anti-inflammato...
What is the current status of trial NCT01514682?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2017-04-17.
What interventions are being tested in trial NCT01514682?
The interventions under investigation include: Placebo (DRUG), Anti-inflammatory Combination Therapy (DRUG).
Who is sponsoring clinical trial NCT01514682?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01514682's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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