Bipolar DisorderNCT04091828
Assessment of Cognitive Functions in Bipolar Patients
An observational study of Bipolar Disorder, run by Assiut University.
Trial summary
Assessment of cognitive function in manic bipolar patient Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Nov 2022
- How long will I take part?
- 4 Years
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: stable people not irritable
Who may be able to join
- Aged 18-55 years
- Of both sex
- Diagnosed as bipolar by DSM-5(patient)
Who cannot join
- Current medical and psychiatric comorbidities which may affect cognitive status.
- Substance abuse or dependence (except nicotine and caffeine)in last month.
- Somatic treatment with drugs known to affect cognitive status (cortisol, antihistamines, etc.)
About this study
Official title: Assessment of Cognitive Functions in Bipolar Disorder Patients
Assessment of cognitive function in manic bipolar patient
Read the detailed description
Assessment of severity of mania and depression in bipolar patients then evaluate their cognitive function.
- Conditions
- Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biplar patients | diagnosed by DSM-5 and divided to manic,depressed and mixed last episod | |
| controlled subject | not have any medical or psychatric problem affect cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of severity of mania in bbipolar patients
EVALUATE manic patients by Young Mania Rating Scale (YMRS)
Measured: 2019-2022
Assessment of severity of depression in bipoiar patients
Evaluate depressed patients by Hamilton Rating Scale for depression(HRS).
Measured: 2019-2022
Assessment of cognitive function in bipoiar patients
Evaluate cognition in included patients by Montreal Cognitive Assessment(MOCA) and P300.
Measured: 2019-2022
Secondary outcomes (1)
Correlation between cognitive state in bipolar patient and(onset age,illness duration and number of episodes).
from history
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 72 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Salama Ahmed Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091828
- Sponsor's protocol ID
- cognition in bipolar patients
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Functions in Bipolar Disorder Patients
- ClinicalTrials.gov ID
- NCT04091828
- Acronym / sponsor ID
- cognition in bipolar patients
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Sep 2019 (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.
Assessment of cognitive function in manic bipolar patient
Detailed description
Assessment of severity of mania and depression in bipolar patients then evaluate their cognitive function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biplar patients | – | –diagnosed by DSM-5 and divided to manic,depressed and mixed last episod |
| controlled subject | – | –not have any medical or psychatric problem affect cognition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- stable people not irritable
Key inclusion criteria (3 listed)
- Aged 18-55 years
- Of both sex
- Diagnosed as bipolar by DSM-5(patient)
Key exclusion criteria (3 listed)
- Current medical and psychiatric comorbidities which may affect cognitive status.
- Substance abuse or dependence (except nicotine and caffeine)in last month.
- Somatic treatment with drugs known to affect cognitive status (cortisol, antihistamines, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of severity of mania in bbipolar patients
Time frame: 2019-2022
EVALUATE manic patients by Young Mania Rating Scale (YMRS)
Assessment of severity of depression in bipoiar patients
Time frame: 2019-2022
Evaluate depressed patients by Hamilton Rating Scale for depression(HRS).
Assessment of cognitive function in bipoiar patients
Time frame: 2019-2022
Evaluate cognition in included patients by Montreal Cognitive Assessment(MOCA) and P300.
1 secondary outcome
Correlation between cognitive state in bipolar patient and(onset age,illness duration and number of episodes).
Time frame: 2019-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Assessment of severity of mania in bbipolar patients (time frame: 2019-2022). The study lists 3 primary outcomes in all. 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 27 Sep 2019.