NCT05878808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 18, 2023

Last Update Submit

May 18, 2023

Conditions

Keywords

BSSIDYBOCSBipolar disorder

Outcome Measures

Primary Outcomes (1)

  • Association of OCD with bipolar I disorder

    1 year

Study Arms (2)

Cases with ocd

Diagnostic Test: Psychometric assessment

Cases without ocd

Diagnostic Test: Psychometric assessment

Interventions

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).

Cases with ocdCases without ocd

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • \- Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder

You may not qualify if:

  • refused to sign the consent, active manic phase, recent substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Obsessive BehaviorSuicideObsessive-Compulsive DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious BehaviorAnxiety DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist professor

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 26, 2023

Study Start

February 1, 2022

Primary Completion

September 15, 2022

Study Completion

January 5, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations