Intravenous chlorpromazine for the treatment of insomnia in end-stage cancer patients with difficulty in oral administratio

Not Applicable

• Conditions: sleep disturbance

• Registration Number: JPRN-UMIN000029365
• Lead Sponsor: Kansai Medical University

Brief Summary

Sleep quality was significantly improved on the day after intravenous chlorpromazine and later.Efficacy rate 3 days after the intravenous chlorpromazine was 0.63 (95% CI: 0.45-0.81). Increased total sleep time and decreased sleep latency time were observed on the day after the treatment, accompanied with improvement of satisfaction with sleep and clearheadedness on arising.On the other hand, no significant improvement was not observed in depth of sleep or number of awakenings during sleep time. After the chlorpromazine treatment, 2 patients dropped out due to difficulty in communication caused by the development of hypoactive delirium.There were no onsets of acute extrapyramidal symptoms, fall, vasculitis, or subcutaneous callus during the treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-30
• Study Start: 2017-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

We focused on only primary insomnia excluding secondary insomnia attributed to delirium or medications. The study excluded psychiatric disorder patients with difficulty in communication such as dementia.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint in this study was sleep quality based on St. Marys Hospital Sleep Questionnaire 3 days after the chlorpromazine treatment as a chlorpromazine efficacy index.