The Benefit of Minocycline on Negative Symptoms in Psychosis: Extent and Mechanisms - The Benefit of Minocycline on Negative Symptoms in Psychosis (BeneMin)

Phase 1

Active, not recruiting

• Conditions: schizophrenia

• Registration Number: EUCTR2010-022463-35-GB
• Lead Sponsor: Manchester Mental Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 170

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified