Protocol summary
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Study aim
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Comparing safety and efficacy of melatonin, trazodone, and clonazepam on the sleep quality of patients with Parkinson's disease
Best choice of drug to improve sleep quality in patients with Parkinson's disease
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Design
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This study is a double-blind clinical trial. Randomization method is a simple randomization. 30 people will be enrolled for each group. The study was performed for one month. Patients were randomly divided into three groups, each receiving either Melatonin or Trazodone or Clonazepam.
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Settings and conduct
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Patients with Parkinson's disease who have sleep disorder based on their medical history, who referred to the neurology clinic of Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran; enrolled in the study. Informed consent will obtain from all patients before inclusion into the study.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients with Parkinson's disease who have sleep disorder based on their history.
Exclusion criteria: A history of drug sensitivity, Hepatic failure Respiratory disorders or apnea, opioid user, cognition disorder and dementia, over 80 years old.
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Intervention groups
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Participants were randomly divided into 3 groups of 30 patients. 30 patients treated with 3 mg of melatonin, 30 patients treated with 50 mg of Trazodone, and 30 patients treated with 1mg of Clonazepam along with pre-existing Parkinson's medication. All trial drugs are administered at night before bedtime.
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Main outcome variables
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Sleep quality, Daytime sleepiness, REM sleep disorder
General information
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Reason for update
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According to the hospital research committee, the present trial and the IRCT20170821035819N3 trial were conducted simultaneously at Roozbeh Hospital by a same principle investigator in the form of a three-arm trial.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170821035819N2
Registration date:
2020-01-29, 1398/11/09
Registration timing:
registered_while_recruiting
Last update:
2021-11-29, 1400/09/08
Update count:
1
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Registration date
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2020-01-29, 1398/11/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-22, 1398/04/01
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Expected recruitment end date
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2020-02-20, 1398/12/01
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Actual recruitment start date
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2019-07-23, 1398/05/01
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Actual recruitment end date
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2020-09-12, 1399/06/22
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Trial completion date
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2020-10-25, 1399/08/04
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Scientific title
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Comparing safety and efficacy of melatonin, trazodone, and clonazepam on the sleep quality of patients with Parkinson's disease in patients referring to the Neurology Clinic of Roozbeh Hospital
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Public title
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Comparing safety and efficacy of melatonin, trazodone, and clonazepam on the sleep quality of patients with Parkinson's disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Parkinson's disease who have sleep disorder based on history.
Exclusion criteria:
Dementia
A history of drug sensitivity
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Age
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From 50 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
90
Actual sample size reached:
93
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Simple randomization
Patients are divided into three treatment groups with 3 mg melatonin (A), 50 mg trazodone (B), and 1 mg clonazepam (C) using a simple random allocation method and a random number table.
We referred "https://www.graphpad.com/quickcalcs/randomize2/" website for randomization, total sample size is 90 and were divided into three groups (A, B, C) each of them 30 patients.
This is a randomized double-blind study. The drugs (Melatonin, Trazodone, and Clonazepam) are packaged in separate but similar packages and labeled A, B, and C on them. As a result, the patient is unaware of the type of drug in each package, and the analyst is also blinded.
Method of administration: For the A group, 3 mg of Melatonin tablets are administered overnight (before bedtime). For the B group, 50 mg Trazodone is given overnight (before bedtime). For the C group, 1mg Clonazepom is given overnight (before bedtime).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This is a double blind study.
The drugs are divided into groups A, B and C by a third person and given to the researcher.
The researcher, participant and evaluator are unaware of the drug, until all data are fully analyzed.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-28, 1397/08/06
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Ethics committee reference number
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IR.IAU.PS.REC.1397.293
2
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Ethics committee
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Approval date
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2018-10-28, 1397/08/06
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1398.094
Health conditions studied
1
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Description of health condition studied
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Sleep disorder of patients with Parkinson's disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson's disease
Primary outcomes
1
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Description
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Sleep quality
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Timepoint
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First time and After 1 month
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Method of measurement
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Pittsburgh sleep quality questionnaire
2
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Description
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Daytime sleepiness
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Timepoint
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First time and After 1 month
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Method of measurement
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Epworth sleepiness score questionnaire
3
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Description
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Sleep Disorder
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Timepoint
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First time and After 1 month
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Method of measurement
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REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Intervention groups
1
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Description
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Intervention group: Patients with Parkinson's disease who have sleep disorder, Take 3 mg Melatonin, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company)
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients with Parkinson's disease who have sleep disorders, Take 50 mg Trazodone, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company)
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Category
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Treatment - Drugs
3
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Description
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Control group: Patients with Parkinson's disease who have sleep disorders, Take 1 mg Clonazepam, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The Article will be publish in international journal and part of the data, such as information about the original outcome can shared without patients identification details.
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When the data will become available and for how long
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2020
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To whom data/document is available
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Published article will be available to everyone.
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Under which criteria data/document could be used
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Data will be made available to research organizations and managers as needed.
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From where data/document is obtainable
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Dr Vajiheh Aghamollaii
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What processes are involved for a request to access data/document
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Reason for request and affiliation person who requested data
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Comments
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