ObsessionsNCT05878808
Obsessions and Suicidality in Youth With Bipolar 1 Disorder
An observational study of Obsessions and Suicide, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Obsessions, Suicide, Bipolar I Disorder
- What is being tested?
- Psychometric assessment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 5 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder
Who cannot join
- refused to sign the consent, active manic phase, recent substance use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obsessions and Suicide in Youth With Bipolar 1 Disorder
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).
Read more
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.
- Conditions
- Obsessions, Suicide, Bipolar I Disorder, Obsessive-Compulsive Disorder
- Being tested
- Psychometric assessment
- Keywords
- BSSI, DYBOCS, Bipolar disorder
- Medical subject headings
- Obsessive Behavior, Suicide, Obsessive-Compulsive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric assessmentDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Cases with ocd | Not described Receives: Diagnostic Test: Psychometric assessment | |
| Cases without ocd | Not described Receives: Diagnostic Test: Psychometric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of OCD with bipolar I disorder
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Feb 2022
- Primary completion15 Sep 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObsessionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Riad abd Elgabbar ayoub, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878808
- Sponsor's protocol ID
- MS-545- 2021
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obsessions and Suicide in Youth With Bipolar 1 Disorder
- ClinicalTrials.gov ID
- NCT05878808
- Acronym / sponsor ID
- MS-545- 2021
- Conditions
- Obsessions, Suicide, Bipolar I Disorder, Obsessive-Compulsive Disorder
- Keywords
- BSSI, DYBOCS, Bipolar disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with ocd | – | Diagnostic Test: Psychometric assessment |
| Cases without ocd | – | Diagnostic Test: Psychometric assessment |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder
Key exclusion criteria (1 listed)
- refused to sign the consent, active manic phase, recent substance use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychometric assessmentEighty 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). | Diagnostic test | Cases with ocd, Cases without ocd |
Primary outcome
Association of OCD with bipolar I disorder
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessions and Suicide, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of OCD with bipolar I disorder (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.