Melatonin and Cognitive-Behaviour Therapy for the treatment of insomnia in individuals with schizophrenia

Phase 4

• Conditions: Schizophrenia; Insomnia; Mental Health - Schizophrenia; Public Health - Health service research

• Registration Number: ACTRN12613000970741
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-30
• Study Completion: 2015-10-07
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Aged 25 to 50 years.
2. A diagnosis of schizophrenia or schizoaffective disorder
3. Length of illness 10-15 years
4. Currently in a clinically stable condition
5. Current insomnia symptoms, characterised by Sleep Onset Latency (SOL) more than 30 minutes, or waking up 3 or more times per night, with an ongoing duration of the sleep problem for at least one month.
6. Stable medication schedule and dosage for the past month
7. English as a first language
8. Using contraceptives (applicable to females only)
9. Confirmation of diagnosis and suitability for the study by the potential participant’s treating psychiatrist
10. Able to provide informed consent

Exclusion Criteria

1. Diagnosis or high indication of sleep-related breathing disorder (e.g. obstructive sleep apnoea), narcolepsy, nightmare disorder, periodic limb movement syndrome, or restless legs syndrome.
2. Suicidality.
3. Allergy to melatonin, corn starch, gelatine
4. BMI >35 (clinical obesity).
5. Co-morbid significant medical conditions (e.g. seizure disorder, traumatic brain injury, dementia, autoimmune disease, liver failure, or kidney failure).
6. Known hereditary problem of galactose intolerance, the LAPP lactase deficiency, or glucose-galactose malabsorption.
7. Pervasive developmental disorder or mental retardation, as defined by DSM-IV or DSM-V criteria.
8. Pregnant or breastfeeding (applicable to females only).

Study & Design

• Study Type: Interventional
• Study Design: Not specified