Aripiprazole as an adjuvant treatment for obsessive and compulsive symptoms in bipolar disorder: A randomized, double-blind, placebo-controlled clinical trial
Investigating the effect of adding aripiprazole as adjunctive therapy in the treatment of obsessive-compulsive symptoms in patients with bipolar disorder
Design
This double-blind clinical trial study has a parallel control group, where the patient and the researcher do not know the type of drug received. 23 patients are allocated in each group. Randomization will be done using a table of random numbers.
Settings and conduct
This study is a double-blind clinical trial in which the patient and the researcher do not know the type of drug received
This study will be conducted on all qualified patients under treatment referring to Golestan Hospital in the period of 2021-2022
Participants/Inclusion and exclusion criteria
Included criteria: age 18 to 60 years, confirmation of bipolar disorder based on DSM-5 criteria.
Exclusion criteria: not having cardiovascular, respiratory, kidney or digestive diseases; Not pregnant, not suffering from drug or alcohol abuse
Intervention groups
Intervention group: They will receive quetiapine with the addition of sodium valproate and aripiprazole. Aripiprazole will be added to the patients' current medications with an initial dose of 5 mg per day, and then the dose will be increased by 5 mg per week to 20 mg per day. The dose of aripiprazole will be adjusted based on the patient's response or patient tolerance. The effect of the drug will be evaluated in weeks 4, 8 and 12.
Control group: they will receive quetiapine plus sodium valproate and will be evaluated in weeks 8 and 12.
Main outcome variables
Severity of obsession, severity of depression, severity of mania
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230814059145N1
Registration date:2023-10-22, 1402/07/30
Registration timing:prospective
Last update:2023-10-22, 1402/07/30
Update count:0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Rakhshan Abiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4428 6943
Email address
abirirakhshan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aripiprazole as an adjuvant treatment for obsessive and compulsive symptoms in bipolar disorder: A randomized, double-blind, placebo-controlled clinical trial
Public title
Aripiprazole as an adjuvant treatment for obsessive and compulsive symptoms in bipolar disorder
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Confirmation of bipolar disorder based on DSM-5 criteria
Exclusion criteria:
Not having cardiovascular, respiratory, kidney or digestive diseases
Not pregnant
Not suffering from drug or alcohol abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is the use of random numbers that are used from random sequence generation software, which refers to the method used to perform a random sequence on the participants in the study, in such a way that before allocating the individual, the allocation group The finding is not clear. By using sealed opaque mail envelopes with a random sequence, each of the generated random sequences is recorded on a card and the cards are placed inside the mail envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients are randomly divided into two control and intervention groups, the control group receives placebo in addition to the drugs consumed, and the intervention group receives aripiprazole in addition to the drugs consumed, and the main partner of the project and the patient remain unaware of the type of treatment.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz, Golestan St., Farvardin Blvd., Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.116
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
Depression
Timepoint
Before the intervention and weeks 4, 8 and 12 after the intervention
Method of measurement
Hamilton
2
Description
Symptoms of mania
Timepoint
Before the intervention and weeks 4, 8 and 12 after the intervention
Method of measurement
Young mania rating scale
3
Description
Obsessive compulsive symptoms
Timepoint
Before the intervention and weeks 4, 8 and 12 after the intervention
Method of measurement
Yale brown obsessive compulsive scale scoring
Secondary outcomes
1
Description
Drug complication
Timepoint
Before the intervention and weeks 4, 8 and 12 after the intervention
Method of measurement
Abnormal Involuntary Movement scale
Intervention groups
1
Description
Intervention group:The intervention group will receive quetiapine with the addition of sodium valproate and aripiprazole. Aripiprazole will be added to patients' current medications at an initial dose of 5 mg per day, and then the dose will be increased by 5 mg per week up to 20 mg per day.Aripiprazole is produced by Actoverco pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: they will receive quetiapine plus sodium valproate and placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Hamzeh rostami
Street address
Golestan hospital, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
Golestanjpspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Farvardin Blvd, Golestan Ave, Ahvaz Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
zakerkish.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?