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Assessment of Cognitive Functions in Bipolar Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04091828
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 27, 2019
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

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

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 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