The effect of adding pentoxifylline to common treatments for bipolar depression
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 86 patients. Random double block is used for randomization
Settings and conduct
Double-blind randomized controlled clinical trial, patients with type 1 and type 2 bipolar disorder who are in a depressive phase are selected. The BDRS questionnaire is completed for them. Patients are then divided into intervention and control groups, and in the control group of patients, the same common treatments for bipolar depression with placebo. (The researcher and the patient are both blind).
The therapeutic effect is evaluated through the validity and reliability of the BDRS questionnaire after 4 and 8 weeks of treatment. In this way, the scores of each person (which is scored from 0 to 60) are compared before entering the study, after 4 weeks and at the end of week 8.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with bipolar disorder types one and two
Criteria for not entering:
Existence of another psychiatric disorder, and medical illnesses and use of anticoagulants and NSAIDs
Intervention groups
Patients with type 1 and type 2 bipolar diagnosis who are in the depressive phase are selected and completed with the BDRS (Bipolar Depression Rating Scale) questionnaire. In addition to routine treatments, they receive 400 mg of pentoxifylline or placebo daily.
Main outcome variables
BDRS questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201119049445N3
Registration date:2022-06-17, 1401/03/27
Registration timing:prospective
Last update:2022-06-17, 1401/03/27
Update count:0
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Hajar Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2127
Email address
salimi85ha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Pentoxifylline to common treatments in depression in bipolar patients
Public title
The effect of adding Pentoxifylline to common treatments in depression in bipolar patients referred to Khorshid Hospital in 1401
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 1 and 2 bipolar disorder with an age range of 18 to 60 years in the depressive phase
Diagnosis of type 1 and 2 bipolar disorder based on DSM-V criteria by a psychiatrist
Have at least five classes of education
Exclusion criteria:
Existence of psychotic symptoms
Existence of another psychiatric disorder
Existence of hypothyroidism
History of cardiovascular disease
Pregnancy or breastfeeding
Existence of hepatic failure
Peptic ulcer
Take antiplatelet drugs or anticoagulants
Receiving non-steroidal anti-inflammatory drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation method is used, for this purpose, the researcher first determines a total sample size and then randomly assigns a set of them to group A and the rest to group B, for example 100 Balls in group A and 100 balls in group B, then the balls are randomly removed from the container without replacement and the created sequence is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
In collaboration with the Faculty of Pharmacy of Isfahan University of Medical Sciences, drugs and placebo with the same shape, color, taste and size are produced, and a specific code is assigned to each so that both the researcher and the participants are unaware. The data are decrypted
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
No 9 ،Jordan building، 14th Ave، North Farabi St، Mardavij St
City
Isfahan
Province
Isfehan
Postal code
8168774661
Approval date
2022-04-28, 1401/02/08
Ethics committee reference number
IR.MUI.MED.REC.1401.037
Health conditions studied
1
Description of health condition studied
Depressive phase of bipolar patients type one and two
ICD-10 code
F31.3
ICD-10 code description
Bipolar disorder, current episode depressed, mild or moderate severity
Primary outcomes
1
Description
Depression score in Bipolar Depression Rating Scale questionnaire
Timepoint
At the beginning of the study, weeks 4 and 8 of the study
Method of measurement
Bipolar Depression Rating Scale questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before the study, weeks 4 and 8 after the study
Method of measurement
20-item BDRS questionnaire
Intervention groups
1
Description
Intervention group: Pentoxifylline tablets, 400 mg, one daily, in the morning, for two months, a product of Amin Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Control group: In addition to the usual treatments for placebo bipolar depression, one daily, in the morning, for two months, made by Isfahan School of Pharmacy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Khorshid hospital
Full name of responsible person
Hajar Salimi
Street address
No 105 ، Dastgheyb Blvd، Ostandari Ave
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
salimi85ha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mortazavi
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Fax
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Salimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 9 ، 14th Ave ، North Farabi St ، Mardavij St
City
Isfahan
Province
Isfehan
Postal code
8168774661
Phone
+98 31 3669 6591
Fax
Email
salimi85ha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Salimi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 9، 14th Ave، North Farabi St ، Mardavij St
City
Isfahan
Province
Isfehan
Postal code
8168774661
Phone
+98 31 3669 6591
Email
dr.mahsa.rahimi.67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Salimi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 9 , 14th Ave, North Farabi St, Mardavij St
City
Isfahan
Province
Isfehan
Postal code
8168774661
Phone
+98 31 3669 6591
Email
dr.mahsa.rahimi.67@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