The purpose of this study is evaluation of the effect of co-enzyme Q10 as adjuvant therapy in depression phase of bipolar disorder patients. This study is a double-blinded randomized study that is done on 74 patients with bipolar disorder depression. Patients are randomly divided into two groups of intervention and placebo. The intervention group receive 200 mg/day of co-enzyme Q10 for 8 weeks. The placebo group receive a placebo completely similar to drug in appearance for 8 weeks. Serum level of TNF-a, IL-10, IL-6, total antioxidant capacity, lipid peroxidation and thiol groups are measured in both groups (intervention and placebo) at the start of the study and 8th week of study and the effect of drug and placebo is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103022965N5
Registration date:2017-06-25, 1396/04/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of coenzyme Q10 on oxidative and nitrosative stress biomarkers in depression phase of bipolar disorder
Public title
Effect of coenzyme Q10 on oxidative and nitrosative stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients between 18-65 years old; patients with diagnosed bipolar depression based on DSM-5 and MADRS score equal to or more than 7 exclusion criteria: patients with anxiety disorder not related to bipolar disorder; 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 adminsitrated any antioxidant agents or supplements during 1 month ago; patients who did not administrated drug or placebo regularly at least in 80% of study duration; pregnant patients; nursing patients
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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 simple randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Hamedan University of Medical Sciences
Street address
Hamedan, Pazhoohesh Crossroad, In front of the Luna park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.UMSHA.REC.1396.89
Health conditions studied
1
Description of health condition studied
Depression phase of bipolar disorder
ICD-10 code
F31.3
ICD-10 code description
Bipolar affective disorder, current episode mild or moderate depression
Primary outcomes
1
Description
TNF-a
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
2
Description
interleukin 6
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
3
Description
interleukin 10
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
4
Description
Total antioxidant capacity
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
5
Description
Thiol groups
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
6
Description
Lipid peroxidation
Timepoint
before the intervention, at the 8th week of intervention
Method of measurement
serum level
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: 200mg coenzyme Q10 twice daily plus standard treatment of bipolar depression for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo plus standard treatment for bipolar depression for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam's clinic
Full name of responsible person
Leila Jahangard
Street address
Imam's clinic, Mirzade Street, Hamadan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
PhD of clinical pharmacy,Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
00
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
PhD of clinical pharmacy,Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
00
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Yasrebifar
Position
student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)