Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.

Key facts

Study ID

NCT04461119

Run by

Newron Pharmaceuticals SPA

People needed

138

Starts

2020-06-16

Expected to finish

2021-03-13

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Demographics
• Age - 18 years, or older
• Sex - male, or non-childbearing potential female unless practicing adequate contraception
• Psychiatric
• Has a current diagnosis of schizophrenia in accordance with DSM-5.
• Has been treated with antipsychotics for at least 2 years.
• Has a total score on the PANSS < 80.
• Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
• Needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent)
• Current symptoms have been stably present for at least one month
• Procedural
• Patient resides at home or in a residential care facility
• If taking clozapine, patient agrees to blood monitoring

You may not qualify if…

• Psychiatric
• Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
• Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).
• Known suicidal risk. A "yes" response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a "yes" response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide attempt within the past 6 months, excludes the patient from the study.
• Patients with a diagnosis of Treatment resistance
• History of neuroleptic malignant syndrome, priapism.
• Current moderate or severe tardive dyskinesia.
• Medical Status
• Abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed on screening EEG. History or current diagnosis of epilepsy or seizure disorder (other than febrile seizures in childhood)
• Insulin-dependent diabetes mellitus
• History or current diagnosis of any neurodegenerative illnesses
• Loss of 500 ml or more of blood during the 3-month period before study enrollment, e.g. as a donor
• Cardiovascular
• A current diagnosis of severe or unstable cardiovascular disease
• Any clinically significant ECG abnormality
• Abnormal vital signs
• Laboratory abnormalities
• Clinically significant abnormalities in routine laboratory examinations
• History and/or presence of hepatitis B and/or C
• Positive results from the HIV serology.
• Positive results of the drug and alcohol tests
• Clinically significant or unstable hypothyroidism or hyperthyroidism
• Concomitant therapy
• Treatment with SSRIs that are moderate/potent inhibitors of CYP2D6 (e.g. fluoxetine)
• Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism

Where it is running

• Behavioral Research Specialists, LLC — Glendale, California, United States
• CBH Health, LLC — Gaithersburg, Maryland, United States
• Community Clinical Research CCR — Austin, Texas, United States
• Help Hospitals Clinical Research Department — Vijayawada, Andhra Pradesh, India
• St. John's Medical College Hospital — Koramangala, Karnataka, India
• Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry — Mangalore, Karnataka, India
• IQRAA Psychiatry Care and Rehabilitation Centre — Kozhikode, Kerala, India
• Deenanath Mangeshkar Hospital Research Center — Pune, Maharashtra, India
• Sujata Birla Hospital — Pune, Maharashtra, India
• Post Graduate Institute of Medical Education and Research — Chandigarh, Punjab, India
• Dayanand Medical College & Hospital — Ludhiana, Punjab, India
• Sri Ramachandra Medical College, Department of Psychiatry — Chennai, Tamil Nadu, India
• Ahana Hospital LLP — Madurai, Tamil Nadu, India
• Asha Hospital — Hyderabad, Telangana, India

Full record on ClinicalTrials.gov

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