A randomized trial administering Minocycline, Acetylsalicylic acid or Pramipexole vs Placebo as add-on to antipsychotics in patients with schizophrenia or schizoaffecive disorder - MAP-S-01

Phase 1

• Conditions: schizophrenia or schizoaffecive disorder

• Registration Number: EUCTR2010-023982-23-RO
• Lead Sponsor: The Stanley Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-25
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1.Male or female, 18-65 years of age, inclusive
2.Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]).
3.Willing and able to provide informed consent, after the nature of the study has been fully explained
4.Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
5.Symptoms: 4 (moderate) or above on CGI-S and ? 4 (moderate) score on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
6.Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
7.Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
2.Pregnant or breast-feeding
3.Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning, history of hemorrhagic CVA or peptic ulcer disease.
4.Patients treated with: any of the trial medications i.e. pramipexole/minocycline/ acetylsalicylic acid, NSAIDs, anti-coagulants, sucralfate, cimetidine, amantadine, mexiletine.
5.Likely allergy or sensitivity to raloxifene/pramipexole/minocycline/acetylsalicylic acid.
6.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
7.Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the efficacy of Pramipexole, Minocycline and Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia. ;Secondary Objective: Primary outcome measure: PANSS total score at the end of the trial. <br>Secondary outcome measures: PANSS positive, negative and general psychopathology scales, Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I), Brief Assessment of Cognition in Schizophrenia (BACS) and rates of drop outs before the end of the trial. <br>;Primary end point(s): Primary outcome measure: PANSS total score at the end of the trial.