Health Condition 1: F25- Schizoaffective disorders Health Condition 2: F20- Schizophrenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria Written informed consent. Both genders, ages 18-55 years (older patients may not tolerate high ACZ dose). Diagnosis of SZ or SZAD (DSM 5). PANSS total score > 60 and Score > 4 on one or more items of the â??positiveâ?? syndrome items (P1-P7), following treatment at therapeutic doses for 6 weeks with different APDs on 2 occasions Stable dose of APD for > 1 month, continued throughout the study. Not participating in another RCT.
Exclusion criteria
Exclusion criteria: Exclusion criteria Substance abuse in the past month/dependence past 6 months, (except nicotine) History or current medical/neurological illnesses that may lead to unstable course, e.g., epilepsy. Pregnancy. ACZ contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addisonâ??s disease/adrenal failure; chronic closed angle-closure glaucoma. Current or prior treatment with ACZ or history of hypersensitivity to ACZ. Intellectual disability as defined in DSM 5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Among patients with treatment resistant (trSZ)9, study the effect of ACZ augmentation on total symptom scores (TSS) based on the Positive and Negative Syndrome Scale (PANSS) 77, compared with Placebo.Timepoint: Baseline, After intervention (Week 8), After cross over (week 20), after follow up (week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include cognitive function, social function and weight. Serum ACZ levels will be monitored.Timepoint: Baseline, After intervention (Week 8), After cross over (week 20), after follow up (week 24). | — |
Countries
India, United States of America
Contacts
ABVIM, Dr.Ram Manohar Lohia Hospital