schizophrenia
Conditions
Interventions
Study Sites
• Colombo North Teaching Hospital
This is a 6-week, open-label, randomized,rater blinded multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of fixe
Sponsors
Dr Ravi Anand
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Male or female not of childbearing potential unless using adequate contraception as determined by their Health Care Provider. 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. 4. Has been diagnosed with schizophrenia within the past 10 years. 5. Has shown treatment-resistance according to psychiatric history, with the last failed treatment documented in the patient’s clinical records. 6. 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]). 7. Has a PANSS total score ? 70 at screening and baseline. 8. 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). 9. Has a Global Assessment of Functioning (GAF) scale total score ? 50. 10. 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). 11. Current level of schizophrenic symptoms has been present for at least one month, but not exceeding one year. 12. Patient is cooperative, able to take oral medication, able to understand the instructions and willing to complete all aspects of the study, and is capable of doing so. 13. Patient is residing with a caregiver at his/her home, or is either in a residential care facility or residing alone, with a caregiver available to help ensure compliance with dosing and scheduled office visits in either situation. 14. Patient has provided written informed consent prior to participating in the study. 15. Patient agrees to be hospitalized overnight if required for trial purposes or if the investigator deems it necessary to ensure the safety of the patient.
Exclusion criteria
Exclusion criteria: 1. DSM-5 diagnosis of schizophreniform disorder, schizoaffective disorder, 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. 2. 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. 3. 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. ) 4. Has a PANSS total score > 90 or a CGI-S rating of 7 (among the most extremely ill patients). 5. History or current diagnosis of other psychiatric or behavioral disorders that may interfere with the conduct or interpretation of the study. 6. Known suicidal risk, or a suicide attempt within the past 2 years, as assessed by the CDSS and/or by psychiatric history. 7. History of neuroleptic malignant syndrome, priapism or moderate or severe tardive dyskinesia. 8. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk (e.g., liver or kidney disease, severe uncontrolled asthma, malignancy). 9. Insulin-dependent diabetes mellitus. Patients with non-insulin-dependent diabetes will be eligible if the following criteria are satisfied: a. Diabetes is considered well controlled, with no changes in treatment regimen for at least 4 weeks prior to screening, b. Diabetes is not newly diagnosed at screening. 10. History or current diagnosis of any neurodegenerative illness, dementia, significant concomitant neurological disease, organic cerebral disease, cerebrovascular disease, focal neurological lesions or history of any trauma resulting in loss of consciousness (during the past 2 years). 11. History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures (other than febrile seizures in childhood). 12. Prior surgery or current medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug, e.g. peptic ulceration, gastric or intestinal surgery, impaired renal or hepatic function, inflammatory bowel disease. 13. Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes, or a QTcF interval prolongation (Fridericia’s correction formula) on the ECG (>450 msec for males; >470 msec for females). The 12-lead ECG will be used for determining the suitability of the patient for inclusion in the study (determination made by the Investigator). Values averaged from the 3 ECG measurements at baseline should be used in determining eligibility. 14. Vital signs (supine) outside the following ranges (measured after 5 minutes supine): a. Systolic blood pressure below 90 or above 150 mmHg; b. Diastolic blood pressure be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation: Safety will be assessed by the following: •Adverse events (AEs) •Vital signs systolic/diastolic blood pressure, pulse, body temperature, respiratory rate, body weight, BMI, waist circumference) •Laboratory evaluations Haematology: Hematocrit, hemoglobin, RBC count, WBC count, differential WBC count, platelets Blood Chemistry Sodium, Potassium, Chloride, Bicarbonate, Calcium, Glucose, BUN, Creatinine, total bilirubin, Albumin triglycerides, AST, ALT, alkaline phosphatase, GGT, LDH, total cholesterol, HDL, LDL, VLDL, CPK, total protein Urinalysis pH, specific gravity, Protein, glucose, ketones, RBC, WBC, casts, Nitrites, bilirubin, hemoglobin Serum prolactin •ECG •Special Diagnostic Tests (evaluated at Screening and/or Baseline) Thyroid function: TSH, free triiodothyronine (T3), and free thyroxine (T4) (Screening) - Virology: Hepatitis B and C; HIV (Screening) - Urine drug screen (Screening, Baseline and final visit) - Alcohol breath test (Baseline) - Serum prolactin (Baseline and final visit) - Serum/urine pregnancy test (Screening, Baseline and final visit) •Physical Examination General appearance, skin, neck (including thyroid), eyes and ears, nose, mouth, throat, lungs, heart, abdomen, back, lymph nodes, extremities •Neurological Examination: Evaluation of the mental status, cranial nerves, muscle strength and tone, reflexes, the sensory system, coordination and gait •A standard eye examination: Visual acuity (Snellen chart), visual field, eye muscles, pupillary response, fundus, tonometry, eyelids, cornea, conjunctiva, sclera and iris will be performed. The examination should be performed by a physician at the site who has the appropriate experience and training. If a clinically significant abnormality is noted that requires expert follow-up, an Ophthalmologist or Optometrist should be consulted. •Seizure checklist •Extrapyramidal Symptom Rating Scale - Abbreviated version (ESRS-A) •Calgary Depression Scale for Schizophr | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Preliminary efficacy of three fixed doses of evenamide Assessed by: - PANSS - CGI-S - CGI-S 2.Determine the effect of evenamide on daily functioning -Based on changes in the Strauss Carpenter level of functioning (LOF) [06 weeks ] | — |
Countries
India
Contacts
Public ContactProf Shehan Williams
Consultant Psychiatrist
Outcome results
None listed