A Phase 4 interventional study of Placebo and Melatonin in Schizophrenia, Schizoaffective Disorder and Bipolar Affective Disorder, sponsored by Lone Baandrup. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by Lone Baandrup · Phase 4, Interventional, and Treatment
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.
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This study's enrollment of 86 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Drug: Melatonin
Drug: Placebo
Both Circadin and placebo are encapsulated in lactose containing gelatin capsules to optimize the blinding.
Prolonged-release melatonin (Circadin®) 2 mg, once daily, 1-2 hours before bedtime.
Also known as: Prolonged-release melatonin, Circadin®
Benzodiazepine (including benzodiazepine related drugs) dose at 6 months follow-up.
The general linear model is used with the outcome measure (dose after 6 months) as the dependent variable and the indicator of intervention and the baseline value as the independent variables. If the assumptions of the model cannot be fulfilled either directly or after transformation a non-parametric method will be used.
Time frame: 6 months follow-up.
Pattern of benzodiazepine dose over time.
The mixed model with repeated measures will be used to analyze the time course. The model is outcome measure = int + baseline + a\*t + b\*t\*t + c\*baseline\*t + d\*baseline\*t\*t + e\*I + f\*I\*t + g\*I\*t\*t where t is time, I the intervention indicator, int the intercept, and a through g the coefficients. Using Akaike's criterium the best co-variance matrix is first chosen among an unstructured, a compound symmetric, or a first order autoregressive.
Time frame: 2, 4, and 6 months.
The fraction of participants who has completely discontinued benzodiazepines 6 months after initiating trial medication.
The analysis will be done using a logistic regression model where logit(p) is the dependent variable, p is the probability of completing the withdrawal, and a binary intervention indicator is the independent variable.
Time frame: 6 months follow-up.
Pattern of P300 amplitude (psychophysiology) over time.
The mixed model with repeated measures will be used to analyze the time course. The model is outcome measure = int + baseline + a\*t + b\*t\*t + c\*baseline\*t + d\*baseline\*t\*t + e\*I + f\*I\*t + g\*I\*t\*t where t is time, I the intervention indicator, int the intercept, and a through g the coefficients. Using Akaike's criterium the best co-variance matrix is first chosen among an unstructured, a compound symmetric, or a first order autoregressive.
Time frame: 2, 4, and 6 months.
Pattern of Brief Assessment of Cognition in Schizophrenia (BACS) composite score over time.
The mixed model with repeated measures will be used to analyze the time course. The model is outcome measure = int + baseline + a\*t + b\*t\*t + c\*baseline\*t + d\*baseline\*t\*t + e\*I + f\*I\*t + g\*I\*t\*t where t is time, I the intervention indicator, int the intercept, and a through g the coefficients. Using Akaike's criterium the best co-variance matrix is first chosen among an unstructured, a compound symmetric, or a first order autoregressive.
Time frame: 2, 4, and 6 months.
Sleep efficiency (polysomnography) at 6 months follow-up.
The general linear model is used with the outcome measure (sleep efficiency) as the dependent variable and the indicator of intervention and the baseline value as the independent variables. If the assumptions of the model cannot be fulfilled either directly or after transformation a non-parametric method will be used.
Time frame: 6 months.
Pittsburgh Sleep Quality Index (PSQI) global score at 6 months follow-up.
The general linear model is used with the outcome measure (PSQI) as the dependent variable and the indicator of intervention and the baseline value as the independent variables. If the assumptions of the model cannot be fulfilled either directly or after transformation a non-parametric method will be used.
Time frame: 6 months.
Pattern of Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ-2) score over time.
The mixed model with repeated measures will be used to analyze the time course. The model is outcome measure = int + baseline + a\*t + b\*t\*t + c\*baseline\*t + d\*baseline\*t\*t + e\*I + f\*I\*t + g\*I\*t\*t where t is time, I the intervention indicator, int the intercept, and a through g the coefficients. Using Akaike's criterium the best co-variance matrix is first chosen among an unstructured, a compound symmetric or a first order autoregressive.
Time frame: 2, 4, and 6 months.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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