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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

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 17, 2019
Last Update Posted Date September 27, 2019
Estimated Study Start Date October 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: September 15, 2019)
  • Assessment of cognitive function in bipoiar patients [ Time Frame: 2019-2021 ]
    EVALUATE manic patients by Young Mania Rating Scale (YMRS)
  • Assessment of cognitive function in bipoiar patients [ Time Frame: 2019-2021 ]
    Evaluate depressed patients by Hamilton Rating Scale for depression(HRS).
  • Assessment of cognitive function in bipoiar patients [ Time Frame: 2019-2021 ]
    Evaluate cognition in included patients by Montreal Cognitive Assessment(MOCA) and P300.
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2019)
Correlation between cognitive state in bipolar patient and(onset age,illness duration and number of episodes). [ Time Frame: 2019-2021 ]
from history
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Cognitive Functions in Bipolar Patients
Official Title Assessment of Cognitive Functions in Bipolar Disorder Patients
Brief Summary 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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 4 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population stable people not irritable
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 22, 2019)
72
Original Estimated Enrollment
 (submitted: September 15, 2019)
50
Estimated Study Completion Date November 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility 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.)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04091828
Other Study ID Numbers cognition in bipolar patients
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Marwa Salama Ahmed Omar, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date September 2019