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NCT02124811 · ClinicalTrials.gov registry record · Phase 4
Minocycline Augmentation to Clozapine
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT02124811: Completed Phase 4 study, sponsored by Emory University.
NCT02124811 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124811, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
The proposed pilot study will compare minocycline augmentation with clozapine in individuals with high vs low inflammation as measured by CRP. Investigators hypothesize that minocycline will be well tolerated and will result in an improvement in the symptoms of schizophrenia, cognition, as well as improve the quality of life for patients preferentially in patients with high CRPs. Investigators plan to use a variety of different scales to measure improvement in the varying symptoms of schizophrenia as well as cognitive function, which will be administered to patients at three week intervals for a total study time of twelve weeks. Investigators hypothesize that minocycline could prove to be an effective, well tolerated, and inexpensive medication for treatment resistant patients with schizophrenia whom have particular difficulties with social interactions, obtaining and maintaining employment, and overall quality of life. Furthermore, investigators hypothesize that the data obtained in this study will contribute to the ongoing exploration of the role of inflammation in the brain of patients with schizophrenia and help understand and target the role of various inflammatory markers in the pathophysiology and treatment of treatment resistant schizophrenia.
Primary Outcome
Positive symptoms (representing unusual thought content) of schizophrenia/schizoaffective disorder were measured with the positive subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Seven items measure the positive symptoms of delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, susp
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
What the finished NCT02124811 record still lists
NCT02124811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT02124811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124811 about?
NCT02124811 is a clinical study titled "Minocycline Augmentation to Clozapine". The proposed pilot study will compare minocycline augmentation with clozapine in individuals with high vs low inflammation as measured by CRP. Investigators hypothesize that minocycline will be well tolerated and will result in an improvement in the symptoms of schizophrenia, cognition, as well as i...
What is the current status of trial NCT02124811?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2015-02. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02124811?
The interventions under investigation include: Minocycline (DRUG).
Who is sponsoring clinical trial NCT02124811?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124811's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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