NCT04091828

Brief Summary

Assessment of cognitive function in manic bipolar patient

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

September 5, 2019

Last Update Submit

September 25, 2019

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (3)

  • Assessment of severity of mania in bbipolar patients

    EVALUATE manic patients by Young Mania Rating Scale (YMRS)

    2019-2022

  • Assessment of severity of depression in bipoiar patients

    Evaluate depressed patients by Hamilton Rating Scale for depression(HRS).

    2019-2022

  • Assessment of cognitive function in bipoiar patients

    Evaluate cognition in included patients by Montreal Cognitive Assessment(MOCA) and P300.

    2019-2022

Secondary Outcomes (1)

  • Correlation between cognitive state in bipolar patient and(onset age,illness duration and number of episodes).

    2019-2021

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

stable people not irritable

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of cognitive function in bipolar patients

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 17, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

September 27, 2019

Record last verified: 2019-09