Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Haloperidol; Haloperidol decanoate; Risperidone

Criteria

Inclusion Criteria:

• All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia. (DSM-V)

• Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion.

• Legal guardian of patients consenting to participate in the study by signing the informed consent form.

Exclusion Criteria:

• Schizoaffective disorder or schizophrenia with somatoform disorders.

• Highly agitated patients who need immediate treatment.

• Patients who are already under treatment for the presenting conditions.

• Patients with comorbid substance abuse or history of organicity

• Patients with known history of dementia, obstructive sleep apnoea syndrome, diabetes mellitus.

• Pregnant and nursing women.

• History of allergy or hypersensitivity to ramelteon.

• Legal guardian of patients not willing to participate in the study.