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Comparison of the effect of bipolar disorder treatment (Lithium+Olanzapin+Clonazepam) and placebo with Riluzole-containing regimen in controlling obsessive symptoms of bipolar patients

Protocol summary

Study aim
Determining the effect of treatment of bipolar disorder and placebo in controlling the symptoms of obsession Determining the effect of treating bipolar disorder in addition to riluzole in bipolar disorder Announcing the results to activists and therapists in the field of mental health in better control of obsessive symptoms in patients with BMD
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 40 patients.
Settings and conduct
Each group will consist of 20 people, one group will be given lithium, olanzapine, clonazepam and riluzole for 16 weeks, and the other group will be given lithium, olanzapine, clonazepam and placebo. Hiding is done using software. Participants do not know which group they are in. The data analyzer does not know which group it is analyzing. The number of people in the intervention and control groups is the same. The number of weeks of drug use is the same, so the patient is blind to the type of treatment. Place:Ostad Mohrari Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria Having DSM 5 criteria for bipolar disorder Having a score higher than 18 in the Y_BOCS test Exclusion criteria pregnancy addiction medical problems
Intervention groups
Each group will consist of 20 people, one group will be given lithium, olanzapine, clonazepam and riluzole for 16 weeks, and the other group will be given lithium, olanzapine, clonazepam and placebo. The evaluation of the intensity of obsessive symptoms in zero week is done by the project manager with the presence and training of the main collaborator with the questionnaire (Y-BOCS) and obsessive symptom changes based on Y-BOCS in 4th, 8th, 12th and 16th weeks .
Main outcome variables
Score obtained in the Y-BOCS questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211118053093N4
Registration date: 2022-08-19, 1401/05/28
Registration timing: prospective

Last update: 2022-08-19, 1401/05/28
Update count: 0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Kimia Sahraian
Name of organization / entity
Eghlid Higher Education Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3886
Email address
leilarazeghian1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of bipolar disorder treatment (Lithium+Olanzapin+Clonazepam) and placebo with Riluzole-containing regimen in controlling obsessive symptoms of bipolar patients
Public title
Riluzole in the control of obsession in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM 5 criteria for bipolar disorder Having a score higher than 18 in the Y_BOCS test
Exclusion criteria:
Pregnancy Addiction Medical problems
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not know which group they are in. The data analyser does not know which group it is analysing. The number of weeks of drug use is the same, so the patient is blinded to the type of treatment.Data analysis is given only data and does not know what treatment was done for witch group
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
Kilometer 13 of Shiraz-Isfahan highway, Ostad Moharreri Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.SUMS.MED.REC.1401.191

Health conditions studied

1

Description of health condition studied
BMD
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

Primary outcomes

1

Description
Yale Brown Obsessive-Compulsive Scale score
Timepoint
week 0and4and8and12and16
Method of measurement
Yale Brown Obsessive-Compulsive Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It includes 20 patients who receive riluzole in addition to the main drugs, and in weeks 0, 4, 8, 12, and 16, they must complete the Yale Brown Obsessive Compulsive Scale questionnaire.
Category
Treatment - Drugs

2

Description
Control group: It includes 20 patients who receive a placebo in addition to the main drugs. And in weeks 0, 4, 8, 12, and 16, they must complete the Yale Brown Obsessive Compulsive Scale questionnaire.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ostad Mohrari Hospital
Full name of responsible person
Leila RazeghianJahromi
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila RazeghianJahromi
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@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
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