A clinical study to determine safety, tolerability and efficacy of drug called Evenamide which is taken orally, in patients with treatment resistant schizophrenia with inadequate benefit from their current antipsychotic medication.
- Conditions
- Other psychotic disorder not due to a substance or known physiological condition,
- Registration Number
- CTRI/2020/09/027537
- Lead Sponsor
- Newron Pharmaceuticals SpA
- Brief Summary
This is a 6-week, open-label, randomized, rater-blinded, multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of fixed doses of evenamide of 7.5 mg bid, 15 mg bid and 30 mg bid as add-on treatment in patients with treatment-resistant schizophrenia on a stable therapeutic dose of an antipsychotic. A minimum of 150 patients will be allocated equally to each of the three treatment groups (50 patients per group). Doses will be initiated in a stepwise fashion. Initially, only the 7.5 mg bid and 15 mg bid doses will be evaluated with a 1:1 randomization scheme. After 50 patients (25 patients in each treatment group) have been treated at these doses, key safety data from these patients will be reviewed by an independent safety monitoring board (ISMB). If this review of the data indicates there are no safety issues, the 30 mg bid dose group will be initiated, and an additional 100 patients will be randomly assigned (1:1:2) to the 7.5, 15 and 30 mg bid treatment groups, with 25, 25 and 50 patients, respectively, enrolled in each group. However, if a decision is made not to include the 30 mg bid dose group in the study, an additional 100 patients will be randomly assigned (1:1) to the 7.5 and 15 mg twice daily treatment groups for a total of 150 patients enrolled, with approximately 75 in each group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
- Psychiatric 3.
- Meets current DSM-5 criteria for schizophrenia.
- Other psychiatric disorders may be present only as lifetime diagnoses if they are not relevant to the current episode of schizophrenia.
- [see Exclusion criteria below] 4.
- Has been diagnosed with schizophrenia within the past 10 years.
- Has shown treatment-resistance according to psychiatric history, with the last failed treatment documented in the patient’s clinical records.
- “Treatment-resistant Schizophrenia†(TRS) is defined as a persistence of significant clinical symptoms despite adequate doses of two standard antipsychotic medications (other than clozapine) from two different chemical classes, including at least one atypical antipsychotic, for at least 6 weeks of treatment each.
- The last failed treatment trial must be documented.
- Has a Clinical Global Impression – Severity of disease (CGI-S) rating of moderately ill to severely ill (score of 4 to 6 [scale 1-7]).
- Has a PANSS total score ≥ 70 at screening and baseline.
- Has a score of 4 (moderate) or more on at least 2 of the following 4 PANSS symptoms of psychosis: P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P6 (Suspiciousness/Persecution) and G9 (Unusual Thought Content); and a total score of at least 20 on the combined total of the PANSS symptom items: P1 (Delusions), P2 (Conceptual Disorganization), P3 (Hallucinatory Behavior), P4 (Excitement), P6 (Suspiciousness/Persecution), P7 (Hostility), and G9 (Unusual thought content).
- Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
- Is in need of anti-psychotic treatment and is currently receiving mono-therapy at a stable dose (minimally for 4 weeks prior to screening) at a minimal recommended therapeutic or higher dose of one antipsychotic (atypical or typical, other than clozapine).
- Current use of quetiapine at a dose of 150 mg or less at night as a soporific will not be considered polypharmacy.
- Current level of symptoms has been present for at least one month, but not exceeding one year.
- Psychiatric 1.
- DSM-5 diagnosis of schizophreniform disorder (295.40), schizoaffective disorder (295.70), or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder (depression will be assessed at screening and baseline using the Calgary Depression Scale for Schizophrenia (CDSS); a score of 7 or higher will be exclusionary).
- History (within three months of study entry) or current diagnosis of Substance Use Disorder as defined by the DSM-5 criteria, with a severity of ‘moderate’ or ‘severe’, or patient is currently abusing drugs or alcohol or has done so in the past year.
- A history of nicotine or caffeine dependence is acceptable; and patients testing positive for THC on the urine drug screen will not be excluded from the study unless there is evidence of toxic psychosis.
- Severity of current episode of psychosis requires that the patient be hospitalized.
- Patients who are chronically hospitalized or in psychiatric daycare, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
- Has a PANSS total score > 90 or a CGI-S rating of 7 (among the most extremely ill patients).
- History or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study.
- Known suicidal risk, or a suicide attempt within the past 2 years, as assessed by the CDSS and/or by psychiatric history.
- History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid) in patients with treatment-resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication. 6 Weeks
- Secondary Outcome Measures
Name Time Method To evaluate preliminary efficacy of the three fixed doses of evenamide, based on symptoms of schizophrenia, as assessed by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression - Change from baseline (CGI-C) and Severity of illness (CGI-S); • To determine the effect of evenamide on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale.
Trial Locations
- Locations (13)
Ahana Hospital LLP
🇮🇳Madurai, TAMIL NADU, India
All India Institute of Medical Sciences
🇮🇳Cuttack, ORISSA, India
Asha Hospital
🇮🇳Hyderabad, TELANGANA, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, PUNJAB, India
Help Hospitals Private Limited
🇮🇳Vizianagaram, ANDHRA PRADESH, India
IQRAA Psychiatric Care and Rehabilitation Centre
🇮🇳Kozhikode, KERALA, India
Mangala Hospital and Mangala Kidney Foundation
🇮🇳Mysore, KARNATAKA, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
Saoji Tupkari Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Sir Ganga Ram Hospital
🇮🇳West, DELHI, India
Scroll for more (3 remaining)Ahana Hospital LLP🇮🇳Madurai, TAMIL NADU, IndiaDr Vikhram RamasubramanianPrincipal investigator9443772233vikhram@ahanahospitals.in