Health Condition 1: F208- Other schizophrenia
Conditions
Interventions
Intervention1: Alpha lipoic acid: Alpha lipoic acid (300mg) given once a day given for 8 weeks
Control Intervention1: Placebo: Matched placebo to 300mg alpha lipoic acid
Sponsors
Archana
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia (DSM-5) verified by MINI v7 by clinician 2. Patients who are treatment resistant according to modified Kane’s criteria 3. Patients on stable dose of antipsychotics for 4 weeks
Exclusion criteria
Exclusion criteria: 1. Patients with severe neurological illnesses, significant intellectual disability and sensory impairment, severe medical illnesses preventing participation into the study 2. Patient diagnosed with other major psychiatric co-morbidity which confounds with biomarker assessment including schizo-affective, mood disorders and substance use dependence 3. Patients who are already on alpha lipoic acid or had been treated with it 4. Patient not willing to give informed consent. (In patients not able to provide consent due to the nature of their illness, informed consent will be sought from the primary care giver of the patient and assent will be taken from the patient) 5. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for Assessment of Positive Symptoms and Scale for Assessment of Negative SymptomsTimepoint: Baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Schizophrenia Cognition Rating Scale 2.The UKU side effects rating scale - scale for the registration of unwanted effects of psychotropics 3. Medication Adherence Rating Scale 4. Serum Brain Derived Neurotrophic Factor levels 5. Serum Malondialdehyde levels & Glutathione (GSH) levels Timepoint: Baseline and 8 weeks;Response RateTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactArchana
All India Institute of Medical sciences
Outcome results
None listed