Schizophrenia Clinical Trial
Official title:
Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia: a Randomized Clinical Trial
In this trial, researchers aim to investigate if prolonged-release melatonin can facilitate the withdrawal of chronic benzodiazepine administration in patients with schizophrenia. Furthermore, researchers will investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life.
Treatment of schizophrenia frequently includes prolonged administration of benzodiazepines
despite lack of evidence of its use. It is often difficult to discontinue use of
benzodiazepines because of development of dependence.
After being randomized to prolonged-release melatonin (Circadin®) 2 mg daily versus matching
placebo, participants are required to slowly taper off their benzodiazepine dose towards no
intake. Data are collected at baseline and at 6 months follow-up regarding medical
treatment, cognition, psychophysiology, sleep, laboratory tests, adverse events,
psychopathology, social function, and quality of life. Data on medical treatment, cognition,
adverse events, social function, and quality of life are also collected at 2 and 4 months
follow-up.
The results from this trial will assess if melatonin has a role in withdrawing long-term
benzodiazepine administration in schizophrenia patients. This group of patients is difficult
to treat and therefore often subject to polypharmacy which may play a role in the reduced
life expectancy compared to the background population. In addition, the data of the trial
are also analyzed as an observational cohort design to investigate the association of
benzodiazepine dose reduction/discontinuation with psychophysiology, cognition, sleep,
quality of life, and other selected variables (not further described below, see trial
protocol). Knowledge of these important clinical aspects is lacking in this group of
patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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