Phase 4
Completed N=10
Minocycline Augmentation to Clozapine
Source: ClinicalTrials.gov NCT02124811 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Aug 2018
Primary outcomePrimary: Positive Subscale Score of the Positive and Negative Syndrome Scale (PANSS) — 22; 22.33; 16; 20.33 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Subscale Score of the Positive and Negative Syndrome Scale (PANSS) |
22; 22.33; 16; 20.33 | — |
| PRIMARY Negative Subscale Score of the Positive and Negative Syndrome Scale (PANSS) |
17; 22.67; 16.5; 22.33 | — |
| PRIMARY Brief Assessment of Cognition in Schizophrenia (BACS) Score |
36; 31.33; 42; 28 | — |
| PRIMARY General Psychopathology Score of the Positive and Negative Syndrome Scale (PANSS) |
33; 36; 27; 37 | — |
| SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Score |
47.5; 64; 53.5; 65.67 | — |
| SECONDARY Global Assessment of Functioning (GAF) Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- Mini International Neuropsychiatric Interview 6.0 diagnosis of schizophrenia or schizoaffective disorder
- Persistent symptoms of schizophrenia as measured by one of the following PANSS items: Total score ≥60, negative subscale ≥ 15, positive subscale ≥ 15, general psychopathology subscale ≥ 30
- Currently taking clozapine and the dose has been adjusted within 100 mg of study enrollment
- Currently taking clozapine for 3 months and documented clozapine level ≥ 350 ng/ml prior to study start
- No other psychotropic medication changes for one month prior to study enrollment
- No new psychosocial interventions for one month prior to study enrollment
- No prior experience on minocycline for greater than 1 week
- May be taking any other psychotropic, dermatologic, or gastrointestinal drugs
Exclusion Criteria
- History of organic brain disease
- Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-TR diagnosis of Mental Retardation or Dementia
- DSM-IV-TR diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
- Pregnancy or lactation
- Known hypersensitivity to tetracyclines
- Current known infection
- Any known neurological disease or medical condition that could impact the measurement of the constructs being assessed
- Inpatient psychiatric hospitalization for worsening of psychiatric symptoms, OR worsening of symptoms requiring a new level of outpatient support, OR started on a new anti-inflammatory medication for greater than one week duration, OR addition of a new psychotropic medication for psychiatric symptom control
- A change in > 15% in PANSS score from the "Lead-In Visit" to the "M0 visit"
Data sourced from ClinicalTrials.gov (NCT02124811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.