NCT04563910

Brief Summary

The current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar I (manic episodes) according to DSM5, patients recruited from inpatient psychiatric unit at department of Neurology and Psychiatry, Assiut University hospitals The current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in Upper Egypt.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

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 19, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2021

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 19, 2020

Last Update Submit

September 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • measure the effect of duration of untreated bipolar disorder on severity (young mania rating scale on admission

    To study the effect of duration of untreated bipolar disorder (manic episodes) on clinical outcomes (severity).

    one year

Secondary Outcomes (1)

  • To measure the effect of duration of untreated bipolar disorder (manic episodes) on clinical outcomes (severity, residual symptoms, duration of admission).

    one year

Study Arms (3)

less than 2 episodes

Patients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes)

Other: young mania rating scale

2-5 episodes

Patients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes)

Other: young mania rating scale

more than 5 episodes

Patients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes)

Other: young mania rating scale

Interventions

questionnaires to the patients and their family after their written consent

Also known as: socioeconomic scale
2-5 episodesless than 2 episodesmore than 5 episodes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, Assiut University Hospitals

You may qualify if:

  • Age group between 18 to 45 years old.
  • Patients diagnosed as mood disorder bipolar I manic episode according to DSM V(2).
  • Clearly consenting to participate in the study.

You may not qualify if:

  • Mood disorder due to substance abuse.
  • Patients in depressive episodes.
  • other mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maggi Raoof Samaan

Study Record Dates

First Submitted

September 19, 2020

First Posted

September 25, 2020

Study Start

September 23, 2020

Primary Completion

September 23, 2021

Study Completion

October 24, 2021

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations