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Assessment of Cognitive Functions in Bipolar Patients

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ClinicalTrials.gov Identifier: NCT04091828
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marwa Salama Ahmed Omar, Assiut University

Brief Summary:
Assessment of cognitive function in manic bipolar patient

Condition or disease
Bipolar Disorder

Detailed Description:
Assessment of severity of mania and depression in bipolar patients then evaluate their cognitive function.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Assessment of Cognitive Functions in Bipolar Disorder Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Assessment of severity of mania in bbipolar patients [ Time Frame: 2019-2022 ]
    EVALUATE manic patients by Young Mania Rating Scale (YMRS)

  2. Assessment of severity of depression in bipoiar patients [ Time Frame: 2019-2022 ]
    Evaluate depressed patients by Hamilton Rating Scale for depression(HRS).

  3. Assessment of cognitive function in bipoiar patients [ Time Frame: 2019-2022 ]
    Evaluate cognition in included patients by Montreal Cognitive Assessment(MOCA) and P300.


Secondary Outcome Measures :
  1. Correlation between cognitive state in bipolar patient and(onset age,illness duration and number of episodes). [ Time Frame: 2019-2021 ]
    from history



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
stable people not irritable
Criteria

Inclusion Criteria:

  • Aged 18-55 years
  • Of both sex
  • Diagnosed as bipolar by DSM-5(patient)

Exclusion Criteria:

  • 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.)
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Responsible Party: Marwa Salama Ahmed Omar, Assessment of cognitive function in bipolar patients, Assiut University
ClinicalTrials.gov Identifier: NCT04091828    
Other Study ID Numbers: cognition in bipolar patients
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders