Evaluating the effect of melatonin on positive and negative symptoms of schizophrenic patients admitted to psychiatry ward of Golestan hospital in 2021-2022
Evaluating the effect of melatonin on positive and negative symptoms of schizophrenic patients admitted to psychiatry ward of Golestan hospital in 2021-2022
Design
Clinical trial with case control group, randomized parallel group, blinded designed on 46 patients. randomization list is prepared by a statisticion.
Settings and conduct
Schizophrenic patients who will be admitted to the psychiatry ward of Golestan hospital and treated with risperidone divided into 2 groups. In the case group, patients will be treated with risperidone and 6 mg melatonin, in the control group patients will be treated with risperidone and placebo. The psychiatrist, nurse, evaluator student, and patients will not be aware of allocation. All of the measures will be registered by one evaluator. Positive, negative, and general signs of schizophrenia will be evaluated with PANSS scale. A reduction of 20 percent or more in PANSS score, during the study, is considered significant.
Participants/Inclusion and exclusion criteria
schizophrenic patients who have admited in psychiatry ward, with age 18 to 65 and have treated with only risperidone, without history of drug reaction to melatonin
Intervention groups
In case group, patients will be treated with risperidone and 6 mg melatonin, in control group patients will be treated with risperidone and placebo
Main outcome variables
Positive and negative symptoms; sleep; metabolic syndrome caused by antipsychotic drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210528051416N1
Registration date:2021-06-21, 1400/03/31
Registration timing:prospective
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
Sanam Anoosheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
anoosheh.sanam@icloud.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of melatonin on positive and negative symptoms of schizophrenic patients admitted to psychiatry ward of Golestan hospital in 2021-2022
Public title
Effect of melatonin in treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have admitted in psychiatry ward of Golestan hospital
Age 18-65 years
Schizophrenic patient according to DSM-5
Satisfaction of patients' guardianship
Schizophrenic patients who have treated with risperidone
Exclusion criteria:
Treatment with any psych medications except for risperidone
Comorbidity of other psychopathologies
Abuse of any substance, drug, or alcohol
Drug reaction to melatonin or placebo
Past history of treatment with clozapine or melatonin
Pregnancy, mental retardation or any other neurologic and neurocognitive disorders, sleep apnea
Proven depression according to Calgary scale
Treatment with ECT in the current episode
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the size of the blocks will be equal. The allocation method in each block will be disclosed using the blinding method. Patients admitted to the study in order of referral. Patients will be distributed in a ratio of 1: 1 and by 11 blocks (the length of each block is 4) (sample size of this study is 44). The randomization sequence will be created using the RandomBetween command in Excel.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be treated with medication packages pre-determined by the study supervisor. The drug packages are quite similar in shape and the patient and the executor of the project are not aware of the contents of the packages. In addition, data collection, patient assessment, and completion of forms will be done by the project manager and her assistant who will not be aware of the content of the package. Data analysis will be performed by the project consultant and the project manager who will not be aware of the contents of the drug packages and only the patient group (group 1 or 2) will be identified for data analysis. Therefore, the study is double-blind and the contents of the two drug groups will not be clear in the patient admission to the study, data collection, and analysis stages.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
Golestan hospital , Farvardin Ave , Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135733118
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.024
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Score of positive and negative symptoms according to PANSS scale
Timepoint
At the start of intervention, 3 weeks and 6 weeks later
Method of measurement
positive and negative syndrome scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will be treated with melatonin tablet (3 mg) which is prepared in RAZAK drug company. The intervention group will receive two melatonin tablets 3 mg (6 mg in total) 30 minutes before bedtime, for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive placebo tablets, which are similar to melatonin tablets (in shape, smell, taste, size and color) and are made from starch powder with the authorized color by the Pharmacy Laboratory of Ahwaz University of Medical Sciences, for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Forouzan Behruzian
Street address
Golestan hospital , Farvardin Ave , Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3038
Email
anoosheh.sanam@icloud.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jorfi
Street address
Ahwaz medical science, Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
jorfi-s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sanam Anoosheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital , Farvardin Blvd , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3038
Fax
Email
anoosheh.sanam@icloud.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sanam Anoosheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital , Farvardin Blvd , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3038
Fax
Email
anoosheh.sanam@icloud.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sanam Anoosheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital , Farvardin Blvd , Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3038
Fax
Email
anoosheh.sanam@icloud.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available