Health Condition 1: F200- Paranoid schizophrenia
Conditions
Interventions
Intervention1: Betahistine: The intervention group will be started on betahistine 8 mg and dose will be increased every third day till a dose of 16 mg TID is attained, antipsychotics (TAU) will be con
Sponsors
Individual
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia as per ICD-11 2. Patients who are currently receiving second generation antipsychotics that cause sedation and deranged metabolic profile (Olanzapine, Risperidone, Clozapine, Quetiapine and Ziprasidone) from the last 3 months 3. Expected to remain on the same antipsychotic medication throughout the active study period although dose could be adjusted if clinically indicated 4. Patients who are willing to get baseline tests for Fasting blood sugar and lipid profile
Exclusion criteria
Exclusion criteria: 1. History asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or any other betahistine contraindication 2. Sedation due to any other reasons like being on drugs any other psychotropics like mood stabilisers, antidepressants, benzodiazepines, antihistaminic, muscle relaxants, opioids etc, sleep disorders (OSA, narcolepsy, circadian rhythm disorders etc), head trauma, encephalitis or brain tumours (assessed by history and verification of medical records) 3. History of aggression or suicidality or any psychiatric emergency 4. Patients receiving prescription or over-the-counter medications taken for the purpose of weight reduction 5. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage changed by more than 50% in the past month 6. Pregnant or breastfeeding 7. New medications which are known to substantially affect weight and glucose lipid profile not permitted during the course of the study 8. History of substance use disorder except for nicotine and caffeine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day time sedation scoresTimepoint: 2 weeks 4 weeks 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in metabolic parameters (Blood pressure, Waist hip ratio, Body mass index, fasting lipid profile, fasting blood sugar)Timepoint: 2 weeks 4 weeks 6 weeks;Brief Psychiatric rating scale (BPRS) total scoresTimepoint: 2 weeks 4 weeks 6 weeks;Adverse eventsTimepoint: 2 weeks 4 weeks 6 weeks;Drop out ratesTimepoint: 2 weeks 4 weeks 6 weeks;Level of functioningTimepoint: 2 weeks 4 weeks 6 weeks | — |
Countries
India
Contacts
Public ContactDr Mamidipalli Sai Spoorthy
All India Institute of Medical sciences, Bibinagar
Outcome results
None listed