Effect of Betahistine on Daytime Sedation and Metabolic Parameters in Patients with Schizophrenia on Second-generation Antipsychotics.

Abstract

Background: Second-generation antipsychotics (SGAs), widely used in the management of schizophrenia, have significant side effects like daytime sedation and metabolic derangement.

Novelty: Betahistine (H1 agonist) has shown promising results for metabolic parameters and is less studied for the management of daytime sedation.

Objectives: This study aims to evaluate the effect of Betahistine on daytime sedation and metabolic parameters in patients with schizophrenia on SGAs from baseline to 6 weeks.

Methods: This open-label randomized control trial will recruit 76 participants (Purposive sampling) aged >18 years, any gender, with a diagnosis of Schizophrenia on SGAs at AIIMS Bibinagar. Participants will be assessed for daytime sedation using the Epworth Sleepiness Scale (ESS) and for metabolic derangement using blood investigations and body measurements. Participants will be randomly allocated (via opaque, sealed envelopes) to two groups. Group 1 will receive Betahistine and treatment as usual, and Group 2 will receive treatment as usual (existing antipsychotics). Participants in both groups will be followed up at 2, 4, and 6 weeks.

Expected outcome: Changes in daytime sedation will be assessed using ESS scores at each follow-up at 2, 4, and 6 weeks. Changes in metabolic parameters will be assessed using blood investigations and body measurements at baseline and 6 weeks.