Determining and comparing the effects of Quetiapine and Trazadone drugs on sleep quality and severity of depression in patients with major depressive disorder
Design
A clinical trial with a control group, with parallel groups, double-blind/randomized/phase 3 on 105 patients/ rand function software of this year's software was used for randomization.
Settings and conduct
The research population of the present study is a group of people suffering from depression disorder (depression means moderate to high depression) who, taking into account the entry and exit criteria, were selected from among the clients to Shahid Muffateh Yasouj Outpatient Clinic and entered knowingly by obtaining a written consent form. will be investigated. Sertraline (SSRI) drug will be given as the main drug in order to maintain and observe ethical principles.
The first group of patients will be treated with quetiapine and the second group with trazodone, both of which will be placed in capsules of the same shape.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from a depressive disorder according to DSM-V criteria and a psychiatrist confirming the diagnosis and having a minimum score of 20 on the Hamilton Depression Scale;
Not taking other drugs to control sleep;
Not suffering from cardiovascular diseases, kidney, diabetes;
Informed consent to participate in the study
Intervention groups
105 patients with depression will be randomly selected and randomization in the present study will be done using sealed envelopes. Patients will be randomly divided into three groups receiving Trazadone, group receiving Quetiapine and control group. The researcher, the person responsible for data collection and the person responsible for the statistical analysis of the data, as well as the patient, will remain unaware of their group until the end of the study
Main outcome variables
Sleep quality and severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231129060218N1
Registration date:2023-12-25, 1402/10/04
Registration timing:prospective
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Zahra Rahami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
zahra.rahami@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-29, 1402/10/08
Expected recruitment end date
2024-02-14, 1402/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and Comparison of Quetiapine and Trazodone Effects on Sleep quality and Depression Severity in Patients with major depressive disorder
Public title
Quetiapine and Trazodone Effects on Sleep quality and Depression Severity in Patients with depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient who suffering major depressive disorder according to DSM _V criteria with minimum score 20 on the hamilton depression scale .not taking other drugs to control sleepi
Not suffering from cardiovascular disease. Kidney. Diabetes
Not taking other drugs to control
Informed constant to participate in the study
Exclusion criteria:
No depression disorder (MDD)
Suffering from cardiovascular disease
Suffering from kidney . Diabetes disease
Dissatisfaction of the patient
Age
From 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
To create a simple random sequence from randomization on the web (www.graphpad.com) and to hide the random allocation, the method of closed envelopes will be used, a number of envelopes, prepared and inside each of the In the letters, the relevant drugs are placed. Finally, the lid of the envelope is glued and delivered to the participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient receives the medicine in a sealed envelope witch is coded
Coding is done by one of the colleagues of the project and the patients are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yasuj university of medical science
Street address
Yasuj University Medical Science, Saheli street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Approval date
2023-10-11, 1402/07/19
Ethics committee reference number
IR.YUMS.REC.1402.106
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression score in Hamilton questionnaire
Timepoint
The beginning of the study and 15 and 30 days after start of the medicine
Method of measurement
Hamilton questionnaire
Secondary outcomes
1
Description
Severity of depression
Timepoint
The beginning of the study and 15 and 30 days after start of the medicine
Method of measurement
Hamilton questionnaire
Intervention groups
1
Description
Intervention group: first؛ use Trazadone drug
Category
Treatment - Drugs
2
Description
Intervention group: second; use Quetiapine drug
Category
Treatment - Drugs
3
Description
Control group: thirth; use placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic
Full name of responsible person
Zahra Rahami
Street address
Shahid Mofateh Clinic, Pasdaran Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Phone
+98 74 3322 2291
Email
Zahra.rahami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed amin hoseini motlagh
Street address
Research Assistant, Yasouj University of Medical Sciences, Shahid Motahari Blvd, yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Phone
+98 74 3334 6079
Email
aminhomo@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Rahami
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Yasuj University Medical Sience, Saheli Park
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Phone
+98 74 3333 7251
Email
Z.rahami.65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra rahami
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Yasuj university medical sience, Saheli Park
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Phone
+98 74 3333 7251
Email
Z.rahami.65@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra rahami
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Yasuj university medical sience, Saheli Park
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591846667
Phone
+98 74 3333 7251
Email
Z.rahami.65@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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