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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05878808
Other study ID # MS-545- 2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date January 5, 2023

Study information

Verified date May 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a comorbidity that is known to increase suicide risk. This study aimed to assess the presence of OCD in youth diagnosed with bipolar I disorder & to evaluate the association between OCD and suicide in the same cohort. Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS). The results revealed that DYBOCS score of group A was 30.23±0.43, & of group B was 18.50±1.88 with a significant difference (p<0.01). There was a significantpositive correlation between BSSI and age, age of onset and YMRS in Group A (p<0.01). The study demonstrated that OCD is a common comorbidity in youth with bipolar I disorder and may be associated with a greater risk of suicide than in youth with bipolar I disorder without co-morbid OCD. Furthermore, co-morbidity of OCD with bipolar I disorder in youth may be associated with younger age of onset and more severe symptoms profile.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 5, 2023
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder Exclusion Criteria: - refused to sign the consent, active manic phase, recent substance use

Study Design


Intervention

Diagnostic Test:
Psychometric assessment
Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS).

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Association of OCD with bipolar I disorder 1 year
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