The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania(sleep , appetite) of type 1 bipolar disorder in randomized, double-blind, placebo-controlled clinical trial
The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania(sleep , appetite) of type 1 bipolar disorder in randomized, double-blind, placebo-controlled clinical trial
Design
A randomized clinical trial, with parallel groups and sample size of 60 (30 in each group)
Settings and conduct
The study will be conducted at Imam Ali Hospital, Karaj on patients with bipolar disorder. Patients who signed informed consent will be randomly divided into two groups. The intervention group receives a valproate sodium tablet (200 mg ) three times daily with spironolactone tablet (50 mg) for 8 weeks and the
control group receives a valproate sodium tablet (200 mg ) three times daily with placebo in tablet form for 8 weeks. The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having DSM-V diagnostic criteria for patients with bipolar disorder with mania phase; Age 18 to 50 years; Their minimum score is 14 based on young mania rating scale
Exclusion criteria: Neurological disease; Cardiovascular and hepatic disease; IQ less than 70; Drug abuse (except nicotine and caffeine); pregnancy; Taking drugs that interfere with spironolactone
Intervention groups
Intervention group: valproate sodium tablet (200 mg ) three times daily with spironolactone tablet (50 mg) for 8 weeks
Control group: valproate sodium tablet (200 mg ) three times daily with placebo in table form for 8 weeks
Main outcome variables
Mood symptoms
Sleep quality improvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190316043072N2
Registration date:2021-04-29, 1400/02/09
Registration timing:registered_while_recruiting
Last update:2021-04-29, 1400/02/09
Update count:0
Registration date
2021-04-29, 1400/02/09
Registrant information
Name
Atefeh Zandifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3255 4132
Email address
zandifaratefe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania(sleep , appetite) of type 1 bipolar disorder in randomized, double-blind, placebo-controlled clinical trial
Public title
The effect of spironolactone as adjunctive therapy on the improvement of cognitive symptoms and mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-V diagnostic criteria for patients with bipolar disorder with mania phase
Age 18 to 50 years
Their minimum score is 14 based on Young Mania Rating Scale (YMRS)
Exclusion criteria:
Neurological disease
Cardiovascular and hepatic disease
IQ less than 70
Drug abuse (except nicotine and caffeine)
pregnancy
Taking drugs that interfere with spironolactone .
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used in this study will be the block randomization method developed by the statistics expert by using the STATA software in a randomization list format. Then, according to the randomization list, the type of intervention for each individual will be written on paper, and the paper will be put in a sealed envelope. Envelopes will be numbered according to the randomization list. The physician will examine the patient's eligibility, and if the patient is eligible, she will tell the hospital research assistant. The research assistant will then provide the sealed envelope to the physician, and the physician will begin the intervention according to the contents of the envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants are aware of the type of treatment
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit, Vice Chancellor for Research, No.20, Saffarian alley, 45 Metri Golshahr street
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.ABZUMS.REC.1399.319
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Mood symptoms
Timepoint
Before and after the intervention
Method of measurement
Young Mania Rating Scale (YMRS), Mini-Mental State Examination (MMSE)
2
Description
Sleep quality improvement
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
Appetite quality improvement
Timepoint
Before and after the intervention
Method of measurement
Simple appetite questionnaire
Intervention groups
1
Description
Intervention group: Taking valproate Sodium tablet (200 mg), 3 times daily with spironolactone tablet (50 mg) , Daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Taking valproate Sodium tablet (200 mg), 3 times daily with placebo in tablet form, Daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr. Atefe Zandifar
Street address
Resalat street, Karaj, Alborze
City
karaj
Province
Alborz
Postal code
3145686695
Phone
+98 26 3252 7576
Email
imamali@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Norisephr
Street address
Vice Chancellor for Research, No.20, Saffarian alley, 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4255
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32563328026
Email
zandifaratefe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32563328026
Email
zandifaratefe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 32563328026
Email
zandifaratefe@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
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