Health Condition 1: F205- Residual schizophrenia
Conditions
Interventions
Intervention1: CARIPRAZINE: TO ADMINISTER LOW DOSE CARIPRAZINE(1.5-3MG) IN ONE ARM ORALLY FOR A PERIOD OF TWO MONTHS
Control Intervention1: AMISULPIRIDE: TO ADMINISTER LOW DOSE AMISULPIRIDE (50-200MG)
Sponsors
Debibrata Acharya
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18-65 Years old 2. All patients irrespective of Gender 3. ICD 10 Diagnosis of Schizophrenia 4. Clinically Stable defined as total score change =20 % on two sequential ratings (every two weeks for a month) on the positive and negative syndrome scale (PANSS) 5. Patients providing valid informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with other psychiatric disorders (e.g., schizoaffective disorder, bipolar disorder, severe axis II disorders) 2. Patients with Treatment resistance (i.e., poor response to =2 antipsychotics of adequate dose and duration during the past 2 years) 3. Patients with any substance abuse (except nicotine) within 3 months of the study or Patients with substance (with the exception of nicotine) dependence within the last 6 months. 4. Patients with suicide risk (based on the psychiatric interview or the Columbia-Suicide Severity Rating Scale [C-SSRS]) 5. Patient under treatment of clozapine 6. Have received electroconvulsive therapy (ECT) in the past 6 months 7. Active Depressive Symptoms; CDSS score >6 8. Patients with Intellectual Developmental Disorder (IDD) 9. Serious medical or neurological illness or seizures 10. History of neurosurgery or head trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in SANS scores 2.Number of patients who show response defined as reduction by greater than 20% Change in SANS score and/or reduction by greater than 20% Change in Negative Symptom domain of PANSS by the end of 8 weeks Timepoint: 1. SANS score to be checked at baseline, 4 weeks and 8 weeks 2. PANSS score to be checked at baseline, 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in PANSS- Positive Symptoms Score, Negative Symtoms Score, Global Psychopathology Scores & Total Scores. 2. Change in Overall disease severity ; Improvement in GAF 3. Side Effect profile;: Checklist for Side-effects of Amisulpiride & Cariprazine including extra-pyramidal symptoms (dystonia, akathisia, NMS & tardive dyskinesia) & sexual side-effects Timepoint: at baseline, 4 weeks & 8 weeks | — |
Countries
India
Contacts
Public ContactDebibrata Acharya
Kalinga Institute of Medical Sciences
Outcome results
None listed