Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Adjunctive vortioxetine therapy: Tablet Vortioxetine 5 mg/day orally for 5 days, after
which the dose will be increased to 10 mg/day. After 5 days, the dose will be increased to 20
mg/d
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inpatients satisfying the ICD 10- DCR (1993) criteria for Schizophrenia with duration of illness > 2 years 2. Age- 18 to 50 years. 3. Score on MoCA< 26. 4. Moderately severe or less ( behaviour, delusions. (Buchanan et al., 2011) 5. Moderate or less ( (Buchanan et al., 2011) 6. CDSS score 7. Patients who give written informed consent for participating in the study.
Exclusion criteria
Exclusion criteria: 1. Any other major comorbid psychiatric diagnosis or significant concurrent medical illnesses. 2. Substance dependence in the last 6 months (excluding nicotine & caffeine). 3. Pregnant or lactating female patients. 4. Patients with organic brain disorder and/or mental retardation. 5. Patients on treatment with medications that can influence cognitive functioning: Anticholinergics (except trihexyphenidyl), 1st generation antipsychotics. 6. Patients on treatment with SSRI, SNRI, TCA or MAOI. 7. Patients who have received ECT in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To explore the effectiveness of Tab. Vortioxetine (20mg/day) as augmenting agent on cognitive functions in patients with schizophrenia when compared to patients receiving placebo. 2. To assess the effectiveness of Tab. Vortioxetine (20mg/day) on the serum levels of TNF-α and IL-6 in patients with schizophrenia when compared to patients receiving placebo. 3. To assess the relationship of serum levels of TNF-α and IL-6 with the changes in the symptom severity of schizophrenia in patients receiving Tab. Vortioxetine (20mg/day).Timepoint: 3 weeks and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of Tab. Vortioxetine (20mg/day) as augmenting agent on positive symptoms and negative symptoms in patients with schizophrenia when compared to patients receiving placebo.Timepoint: 3 weeks and 6 weeks | — |
Countries
India
Contacts
Public ContactShalini Sarangi
Central Institute of Psychiatry
Outcome results
None listed