Evaluating an effective way to increase the sleep quality in GAD or MDD patients
Design
A clinical trial with a control group, with parallel, double-blind, randomized groups, will be performed on 78 patients. The RNT table was used for randomization.
Settings and conduct
Drug and placebo packages will be coded per random number table and only information about to use the medication and code of the product will be written on the product label. Patient information and information regarding study outcomes will be recorded using the special code and all of this work doing at Tabriz university of medical sciences
Participants/Inclusion and exclusion criteria
1. Patients with a diagnosis of Generalized Anxiety Disorders or Major Depressive Disorders approved by a psychiatrist
2. 18 years or older
3. Groningen Sleep Quality Score more than 6 when medication started
4. Pittsburg Sleep Quality Index more than 5 when medication started
Intervention groups
Patients with a diagnosis of Generalized Anxiety Disorders or Major Depressive Disorders approved by a psychiatrist and supervised at the Razi Hospital Psychiatric Disorders Clinic will be included in the study. At the time of admission, patients' sleep quality was assessed using the Groningen Sleep Quality Score, and patients with a score of 6 or higher, PSQI above 5 will be included in the study. The study will be a randomized double-blind clinical trial with placebo control.
The effects of melatonin over 4 weeks in patients with MDD or GAD are assessed using grading scales for depression and sleep quality.
Main outcome variables
Pittsburg Sleep Quality Index Decreases
Groningen Sleep Quality Score Decreases
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210921052540N1
Registration date:2021-11-04, 1400/08/13
Registration timing:prospective
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
Sina SeyedImani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 0307
Email address
seyedimani.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-16, 1400/08/25
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of melatonin in improving sleep quality in patients with generalized anxiety disorder or major depressive disorder
Public title
Melatonin in Depression or Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of depression or anxiety by a doctor
PSQI score above 5
GSQS score above 6
Exclusion criteria:
PSQI score less than 5
GSQS score less than 6
Patient dissatisfaction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be carried out useing a random number table, the person responsible for patient allocation by RNT-table will be bilnded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo packages will be coded per random number table and only information about to use the medication and code of the product will be written on the product label. Patient information and information regarding study outcomes will be recorded using the special code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
6th floor, Pharmacotherapy Department, Tabriz University of Medical Sciences Pharmacy Faculty, Attar Neyshabouri st., Tabriz, East Azerbaijan , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167747899
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.401
Health conditions studied
1
Description of health condition studied
Sleep Disorder
ICD-10 code
G47.01
ICD-10 code description
Insomnia due to medical condition
Primary outcomes
1
Description
Groningen Sleep Quality Score
Timepoint
Base line and after a month
Method of measurement
Questionnaire
2
Description
Pittsburgh Sleep Quality Index
Timepoint
Base line and after a month
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with in ths group will receive Melatonin 3mg every night before sleep
Category
Treatment - Drugs
2
Description
Control group: Patients with in ths group will receive Melatonin 3mg every night before sleep
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Psychiatric disorders of Imam Reza hospital of Tabriz University of Medical Sciences
Full name of responsible person
Sina SeyedImani
Street address
No. 105, 1st Floor, Clinic of Psychiatric disorders of Imam Reza hospital of Tabriz University of Medical Sciences, Golgasht St., Tabriz, East Azarbaijan, Iran
3rd Floor, Central Building no. 2, Golgasht St., Tabriz, East Azarbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Soldouzian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
6th floor, Pharmacotherapy Department, Tabriz University of Medical Sciences Pharmacy Faculty, Attar Neyshabouri St., Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14766-51664
Phone
+98 41 3337 2250
Email
dr.mohammadsolduzian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Soldouzian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
6th floor, Pharmacotherapy Department, Tabriz University of Medical Sciences Pharmacy Faculty, Attar Neyshabouri St., Tabriz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14766-51664
Phone
+98 41 3337 2250
Email
drmohammadsolduzian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sina SeyedImani
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 101, Narenjestan, Aseman Residental Complex, Aseman st., El Goli St., Tarbiz, East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167747899
Phone
+98 41 3333 5925
Email
seyedimani.s@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to data confidentiality and recording the data using specialize code, personal information of the patient won't be shared, rest of the information may be available