Evaluation the efficacy of resperidon to deminish obsession symptoms in bipolar patients
Design
This clinical trial has a control group, it has parallel, double-blind, phase 3, randomized groups, which is conducted on two groups of 20 patients. Both groups received standard treatment, and the case group received risperidone and the control group received placebo
Settings and conduct
Among the admitted patients and patients referred to the Ebnesina psychiatric clinic in Shiraz who are simultaneously suffering from bipolar disorder and obsessive compulsive disorder and have passed the acute stage of bipolar depression or mania and are in a stable condition, the selected patients received the desired drug and placebo. They are checked at the mentioned intervals of 4, 8 and 12 weeks. The packaging of the drugs and placebo was done by a third person other than the researcher and the evaluator of the results
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-suffering from bipolar disorder type 1 or 2 ; 2-coincidence of bipolar disorder and obsessive compulsive disorder; 3-Literacy for reading and writing; 4-Absence of extrapyramidal movement disorders; 5- consent for entering study
Exclusion criteria:
Acute phase of mania or depression ;Major medical conditions(cardiovascular-respiratory-renal-digestive) ;Pregnancy
Intervention groups
in case group containing 20 patients, risperidone is administered for 3 months and patients are checked for obsession symptoms based on Yale-Brown questioner after 4, 8 and 12 weeks post treatment. in control group placebo is administered instead of risperidone. both groups receive standard treatment containing Li and benzodiazepine if needed.
Main outcome variables
Obsessional symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140926019295N3
Registration date:2022-09-13, 1401/06/22
Registration timing:registered_while_recruiting
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Ali Sahraian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
sahraian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of risperidone efficacy versus placebo in treatment of obsessive compulsive disorder symptoms in bipolar patients
Public title
Evaluation of risperidone efficacy versus placebo in treatment of obsessive compulsive disorder symptoms in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
DSM-5 criteria for Bipolar disorder type 1 or 2
yale-brown score higher than 61
Coincidence of Bipolar disorder and obsessive-compulsive disorder
Exclusion criteria:
Acute phase of mania or depression
Major medical conditions(cardiovascular-respiratory-renal-digestive)
Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be permutation block method in such a way that A represents the person who receives the intervention and B represents the person who receives the control. This method considering blocks of four so that the total number of possible permutations of four is equal to 6, including: ABAB, BABA, AABB, BBAA and BAAB ABBA. Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 40 items that includes 10 blocks of 4 items (total number of samples = 40 x 10) is produced (using from the computer) and the order of assigning each of the methods to each of the samples participating in the study is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients and the evaluator who perform the Yale-Brown test to measure the severity of obsessive-compulsive symptoms are not aware of the grouping and the type of medication received (risperidone versus placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
chamran Blvd. hafez hospital. psychiatry department
City
shiraz
Province
Fars
Postal code
7144714189
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.SUMS.REC.1401.113
Health conditions studied
1
Description of health condition studied
اختلال وسواسی جبری-اختلال دوقطبی
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessional symptoms
Timepoint
4 and 8 weeks after receiving risperidone
Method of measurement
yale brown questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: risperidone with initial dose 5mg for 12 weeks and at intervals of 4, 8, and 12 weeks, the level of obsessive symptoms will be evaluated using the Yale Brown questionnair
Category
Treatment - Drugs
2
Description
Control group: In the control group, like the intervention group, they receive standard treatment including lithium and benzodiazepine, and they are also given a placebo drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne sina clinic
Full name of responsible person
ali sahraian
Street address
Hafez st. Ebne sina hospital
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3228 9604
Email
mghavipisheh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Zand st.
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3228 9604
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Ghavipisheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blv. Hafez hospital- psychiatry department
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3647 9319
Email
mghavipisheh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry- Hafez hospital
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3627 9319
Fax
+98 71 3627 9319
Email
sahraian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Ghavipisheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blv. Hafez hospital- psychiatry department
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3647 9319
Email
mghavipisheh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information is provided
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
No - There is not 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