Comparison of the therapeutic effect of allopurinol versus placebo on clinical signs and symptoms in patients with manic bipolar disorder: a double blind randomized clinical trial
Objectives: To compare the therapeutic effect of allopurinol versus placebo on clinical symptoms in patients with manic bipolar disorder.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible patients with manic bipolar disorder who will refer to Baharan Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 45 years; manic bipolar disorder; Score of YMRS equal to or greater than28.
Exclusion criteria: Pregnancy; breastfeeding; sensitivity to allopurinol; mental disability; diabetes; hypertension; hypothyroiditis; hyperthyroiditis; convulsion; liver failure; renal failure.
Intervention group: Routine treatment plus allopurinol 300 mg twice a day orally for 4 weeks.
Control group: Routine treatment plus placebo capsule (including cellulose) twice a day orally for 4 weeks.
Primary outcome: Severity of clinical signs and symptoms using YMRS questionnaire before intervention and one, two, three, and four weeks after intervention.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710089014N193
Registration date:2017-10-17, 1396/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2007-10-23, 1386/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of allopurinol versus placebo on clinical signs and symptoms in patients with manic bipolar disorder: a double blind randomized clinical trial
Public title
Comparison of the therapeutic effect of allopurinol versus placebo on clinical signs and symptoms in patients with manic bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 45 years; manic bipolar disorder; Score of YMRS equal to or greater than28.
Exclusion criteria: Pregnancy; breastfeeding; sensitivity to allopurinol; mental disability; diabetes; hypertension; hypothyroiditis; hyperthyroiditis; convulsion; liver failure; renal failure.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Zahedan University of Medical Sciences, Dr Hesabi Square
City
Zahedan
Postal code
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1396.150
Health conditions studied
1
Description of health condition studied
Manic bipolar disorder
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
Severity of clinical signs and symptoms
Timepoint
Before intervention and one, two, three, and four weeks after intervention
Method of measurement
Using YMRS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus allopurinol 300 mg twice a day orally for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus placebo capsule (including cellulose) twice a day orally for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan Hospital
Full name of responsible person
Mozhdeh Rigi
Street address
Baharan Hospital, Imam Khomeini Ave.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr Noor Mohammad Bakhshaei
Street address
Zahedan University of Medical Sciences, Dr Hesabi Square
City
Zahedan
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 and Technology, Zahedan 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
Baharan Hospital
Full name of responsible person
Mozhdeh Rigi
Position
Medical Student
Other areas of specialty/work
Street address
Baharan Hospital, Imam Khomeini Ave.
City
Zahedan
Postal code
Phone
+98 37 7933 5154
Fax
Email
rigi.mozhdeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baharan Hospital
Full name of responsible person
Dr Mohammad Davood Mohebi
Position
Psychiatrist
Other areas of specialty/work
Street address
Baharan Hospital, Imam Khomeini Ave.
City
Zahedan
Postal code
Phone
+98 37 7933 5154
Fax
Email
mdmohebi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+81 38380090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)