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Status unknownNCT04563910Updated Sep 25, 2020

Impact of Duration of Untreated Manic Episodes on Clinical Outcome

An observational study in Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-09-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 45 Years
Sex
All
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Study 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.

Read the detailed description

Mood disorder carries a major burden in our country as it represents 15% of inpatients and 20% of outpatients in mental hospitals in Egypt

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.

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

02

Conditions studied

  • Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis

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03

In context

Mania

166 studies on the registry are indexed under Mania; 13 are open to participants now.

This study's planned enrollment of 100 is below the median of 168 across 25 observational studies indexed under Mania.

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Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • -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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otheryoung mania rating scale

    questionnaires to the patients and their family after their written consent

    Also known as: socioeconomic scale

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What researchers measure

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).

    Time frame: 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).

    residual symptoms measured by young mania rating scale on discharge

    Time frame: one year

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Study locations

1 site
  • Assiut university
    Assiut, Egypt
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References and documents

Related links

Individual participant data

Plan to share: Undecided — i will share after finishing my research

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2020; primary completion for Sep 2021, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2020
First posted
Sep 25, 2020
StartEst.
Sep 23, 2020
Primary completionEst.
Sep 23, 2021
CompletionEst.
Oct 24, 2021
Last update
Sep 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04563910
Lead sponsor
Assiut University
Responsible party
Maggi Raoof (Maggi Raoof Samaan, Assiut University) — Principal investigator
First posted
Sep 25, 2020
Start date
Sep 23, 2020 (estimated)
Primary completion
Sep 23, 2021 (estimated)
Completion
Oct 24, 2021 (estimated)
Last update
Sep 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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