The purpose of this study is evaluation of the effect of co-enzyme Q10 as adjuvant therapy in patients with depression.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 74 patients. Randomization is done by permutation block method. In each block, depending on the sample size, five patients are admitted. Random allocation help software is also used.
Settings and conduct
The study is done at Psychology clinic of Rasoul Akram hospital in Tehran. The study population is patients with depression. The study is done in a double-blind manner. Patients based on permutation block method divided into two groups of intervention and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 18-65 years old; patients with diagnosed depression based on Beck score. Non-inclusion criteria: patients with mixed episodes of depression and manic or hypomanic phase; patients with severe disease; patients who administrated antidepressant agents during 1 month ago; patients who administrated any antioxidant agents or supplements during 1 month ago; pregnant patients.
Intervention groups
The intervention group receives 200 mg/day of co-enzyme Q10 for 8 weeks. The control group receive a placebo completely similar to drug in appearance for 8 weeks.
Main outcome variables
Severity of depressive symptoms in patients based on Beck Inventory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161204031229N5
Registration date:2021-09-13, 1400/06/22
Registration timing:registered_while_recruiting
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Azadeh Eshraghi
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy-International Campus, Iran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 86709
Email address
eshraghi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of coenzyme Q10 and placebo on the severity of depressive symptoms in the treatment of patients with (major) depression
Public title
The effect of Coenzyme Q10 in depressed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18-65 years old
Patients with diagnosed depression
Exclusion criteria:
Patients with mixed episodes of depression and manic or hypomanic phase
Patients with severe disease
Patients who administrated antidepressant agents during 1 month ago
Patients who administrated any antioxidant agents or supplements during 1 month ago
Pregnant patients
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:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted randomization method of block randomization. All blocks are the same size, and in this two-group experiment we will have blocks of size 6 (including 3 participants in the intervention and 3 participants in the control groups). Random allocation software is also used to randomize random sequence production software (Random allocation software). For concealment, we also use concealment allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All participants in the study, including participants, clinical caregivers, researchers, etc., are kept blind. Of course, before starting the study, informed consent is obtained from the participants. But because drugs and placebo are similar in shape and different in content, practically no one knows their true nature
Placebo
Used
Assignment
Parallel
Other design features
Neither the participants or the experimenters know who is receiving a particular treatment and the patients are randomized into intervention group or placebo group by cards shuffling method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-18, 1400/01/29
Ethics committee reference number
IR.IUMS.REC.1400.077
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Depression severity
Timepoint
Before the intervention, at the 4th week of intervention, at the 8th week of intervention
Method of measurement
By beck inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 200 mg coenzyme Q10 twice daily plus standard treatment of depression for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo plus standard treatment for depression for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Azadeh Eshraghi
Street address
Niayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8670 2504
Email
aepharm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azade Eshraghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2030
Email
eshraghi.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azade Eshraghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2030
Email
eshraghi.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azade Eshraghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2030
Email
eshraghi.a@iums.ac.ir
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