The Benefit of Minocycline on Negative Symptoms in Schizophrenia: Extent and Mechanisms

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate if minocycline limits the development of negative symptoms in early psychosis and to test via what mechanism of action this change occurs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manchester
• Collaborators: Cambridgeshire and Peterborough NHS Foundation Trust; Camden and Islington NHS Foundation Trust; Central and North West London NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; Greater Manchester West Mental Health NHS Foundation Trust; King's College London; Lancashire Care NHS Foundation Trust; Manchester Mental Health & Social Care Trust; NHS Borders; NHS Fife; NHS Lothian; North East London Foundation Trust; Salford Royal NHS Foundation Trust; South London and Maudsley NHS Foundation Trust; University College, London; University Hospital Birmingham NHS Foundation Trust; University of Birmingham; University of Cambridge; University of Edinburgh; West London Mental Health NHS Trust
• Treatments: Minocycline

Criteria

Inclusion Criteria:

• Meeting DSM-IV criteria for schizophrenia, schizophreniform or schizo-affective psychosis as assessed by the research team

• In an episode as defined by the presence of positive symptoms measured by Positive and Negative Syndrome Scale with a score higher than two in items 1,2,3 or 6 in the Positive scale

• In contact with early intervention community or in-patient service

• Within 5 years of first diagnosis

• Intelligence quotient (IQ) greater than 70

• Participants and their partners must be willing to use effective birth control throughout the study and seven days after stopping trial medication. Females should have a negative pregnancy test

• Able to understand and willing to give written informed consent

• Fluent in English

Exclusion Criteria:

• Current substance misuse diagnosis that in the opinion of the investigator may interfere with the study

• Patients who, in the investigator's judgement pose a current serious suicidal or violence risk

• Use of tetracycline antibiotics within 2 months of the randomisation visit or history of sensitivity or intolerance for this type of antibiotics

• History of Systemic Lupus Erythematosis (SLE) or a history of SLE in a first-degree relative

• Use of any investigational drug within a month of randomisation visit

• Relevant current or past hematologic, hepatic, renal, neurological or other medical disorder in the opinion of the principal investigator (PI) or the responsible medical officer (RMO) may interfere with the trial

• Taking medical treatments that could seriously interact with minocycline as described in the summary of product characteristics (SPC) and judged by the PI or the RMO

• Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator

• Previous randomisation in the present study

• Pregnant or breastfeeding

• Meeting MRI exclusion criteria as defined by local scanning centres