Add-on to antipsychotics in the treatment of schizophrenia

Phase 1

• Conditions: schizophrenia and schizoaffective disorder.; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10039621Term: Schizoaffective disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000415-25-RO
• Lead Sponsor: Clinirx Tangent Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 232

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
8.Onset of illness, defined as the first admission for psychosis, was 10 years or less before recruitment.

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 232
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, cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning, history of hemorrhagic CVA or peptic ulcer disease.
4.Patients suffering from diabetes or ischemic cardiac disease
5.Patients treated with: any of the trial medications i.e. NSAIDs, anti-coagulants or statins on a daily basis.
6.Likely allergy or sensitivity to trial medications
7.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
8.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
9.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 and safety of Naproxen, Simvastatin and their combination, compared to placebo as add-on to anti-psychotic in the treatment of patients with schizophrenia and schizoaffective disorder;Secondary Objective: 1. PANSS positive, negative and psychopatology scales<br>2. Clinical Global Impression Scale Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I)<br>3. Brief Assessment of Cognition in Schizophrenia (BACS)<br>4. Rate of drop outs before the end of the trial ;Primary end point(s): PANSS total score at the end of the trial.;Timepoint(s) of evaluation of this end point: At the end of the trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.PANSS positive, negative and general psychopathology scales, <br>2.Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I), <br>3.Brief Assessment of Cognition in Schizophrenia (BACS) and <br>4.Rates of drop outs before the end of the trial.;Timepoint(s) of evaluation of this end point: The end of the trial.