schizophrenia
Conditions
Interventions
Trade Name: Acnamino MR 100mg
Product Name: Minocycline
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: (2E,4S,4aR,5aS,12aR)- 2-(amino-hydroxy-m
Sponsors
Manchester Mental Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 16-35 years 2) Current DSMIV diagnosis of schizophrenia, schizophreniform or schizo-affective psychosis, psychosis NOS as assessed with the clinical team. 3) In an episode as defined by a) an onset or exacerbation of symptoms and b) with continuing positive symptoms scoring at least mild (>2) on items P1,P2 or P6 of the PANSS within the last month 4) In contact with early intervention, community or in-patient services, 5) Within 3 years of onset of symptoms 6) Current IQ greater than 70 7) Female patients must use effective birth control with a negative pregnancy test 8) Able to understand and willing to give written informed consent 9) Fluent in English Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) Current substance misuse diagnosis that in the opinion of the investigator may interfere with the study. Urine toxicology screens will be used to monitor drug use. 2) Patients who, in the Investigator’s judgment pose a current serious suicidal or violence risk 3) Prior tetracycline use within 2 months of baseline visit or history of sensitivity or intolerance 4) History of systemic lupus erythematosis (SLE) or a history of SLE in a first-degree relative 5) Use of any investigational drug within 30 days of baseline visit 6) Relevant current or past haematologic, hepatic, renal, neurological or other medical disorder that in the opinion of the investigator may interfere with the study 7) Clinically significant deviation from the reference range in clinical laboratory test results as judged by the Investigator. 8) Previous randomisation in the present study. 9) Pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm that minocycline benefits the negative symptoms of schizophrenia when taken early in the course of the illness and to understand how it does so. To determine whether minocycline acts by protecting brain cells from damage, by lessening inflammation or by improving mental functions (thinking and reasoning).;Secondary Objective: 1- Does minocycline reduce weight gain induced changes by standard antipsychotic treatments (APD)? 2- Do improvements in negative symptoms translate into improved social and occupational functioning and quality of life (QoL)?;Primary end point(s): Primary efficacy outcome variable: Negative symptom severity at 12 months as defined by negative factor subscale score on the PANSS. This is the gold standard scale for comprehensively rating symptoms of schizophrenia. The negative symptom factor subscale is composed of 7 items each rated 1-7. Primary mechanistic biomarker outcome variables: 1) Medial prefrontal grey matter volume, 2) Circulating cytokine IL-6 concentration, 3) Dorsolateral prefrontal cortex blood oxygen level dependent (BOLD) response, % correct and connectivity during the N-back task, | — |
Countries
United Kingdom
Outcome results
None listed