E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 1. PANSS total score, 2. PANSS negative score |
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E.2.2 | Secondary objectives of the trial |
1. Udvalg for Kliniske Undersogelser (UKU), 2. Abnormal Involuntary Movement Scale (AIMS) and 3. Other physiologic measures (Physiologic cardiovascular and pulmonary measures with automated heart monitor). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
PANSS total score at the end of the trial. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. PANSS positive, negative and general psychopathology scales, 2. Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I), 3. Brief Assessment of Cognition in Schizophrenia (BACS) and 4. Rates of drop outs before the end of the trial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |