Add-on to antipsychotics in the treatment of schizophrenia

Phase 1

• Conditions: schizophrenia; MedDRA version: 17.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-002176-83-RO
• Lead Sponsor: Clinirx Tangent Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-05
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Males and females between 19 to 40 years of age.
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 diagnosis of schizophrenia as confirmed by modified SCID.
5.First diagnosed with schizophrenia no more than 5 years before the trial
6.Total PANSS score at baseline = 60.
7.Patients in an acute psychotic episode requiring full-time hospitalization according to clinical referral by the relevant mental health service.
8.During the life time must have been on an antipsychotic drug for at least 6 months
9.No change in psychotropic medication over the last 1week before baseline.
10.Female participants willing to have a pregnancy test before treatment.
11.Willing to remain under observation for the entire 4 weeks trial period

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Unstable medical disease, such as malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
2.Prior history of intolerance to Sodium Nitroprusside.
3.Presence of a seizure disorder, not including clozapine-induced seizures.
4.Currently taking clozapine and/or antihypertensive medication.
5.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
6.Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-IV criteria.
7.Clinically significant use of illicit substances or alcohol in the past 3 months.
8.Pregnant or breastfeeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: The objective of the study is to evaluate the efficacy of Sodium Nitroprusside, administered intravenously, compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia in an acute exacerbation<br> 1. PANSS total score,<br> 2. PANSS negative score<br> ;<br> Secondary Objective: 1.Udvalg for Kliniske Undersogelser (UKU),<br> 2.Abnormal Involuntary Movement Scale (AIMS) and<br> 3.Other physiologic measures (Physiologic cardiovascular and pulmonary measures with automated heart monitor).<br> ;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
<br> 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.<br> ;Timepoint(s) of evaluation of this end point: The end of the trial.