Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed DiagnosisNCT04563910
Impact of Duration of Untreated Manic Episodes on Clinical Outcome
An observational study of Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis
- What is being tested?
- young mania rating scale
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Sep 2020to 24 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 100 patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, Assiut University Hospitals
Who may be able to join
- -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.
Who cannot join
- -Mood disorder due to substance abuse.
- Patients in depressive episodes.
- other mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Duration of Untreated Bipolar Disorder (Manic Episodes) on Clinical Outcome
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
- Being tested
- young mania rating scale
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
young mania rating scaleOther
Also called socioeconomic scale
questionnaires to the patients and their family after their written consent
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: young mania rating scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start23 Sep 2020 (estimated)
- Primary completion23 Sep 2021 (estimated)
- Study completion24 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed DiagnosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maggi Raoof, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563910
- Sponsor's protocol ID
- 17101199
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will share after finishing my research
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Duration of Untreated Bipolar Disorder (Manic Episodes) on Clinical Outcome
- ClinicalTrials.gov ID
- NCT04563910
- Acronym / sponsor ID
- 17101199
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (estimated)
- Primary completion
- 23 Sep 2021 (estimated)
- Study completion
- 24 Oct 2021 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| less than 2 episodes | – | Other: young mania rating scalePatients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes) |
| 2-5 episodes | – | Other: young mania rating scalePatients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes) |
| more than 5 episodes | – | Other: young mania rating scalePatients were classified into 3 groups according to number of episodes (1-2 episodes, 3-5 episodes, more than 5 episodes) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 100 patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, Assiut University Hospitals
Key inclusion criteria (3 listed)
- -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.
Key exclusion criteria (3 listed)
- -Mood disorder due to substance abuse.
- Patients in depressive episodes.
- other mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| young mania rating scaleAlso: socioeconomic scalequestionnaires to the patients and their family after their written consent | Other | 2-5 episodes, less than 2 episodes, more than 5 episodes |
Primary outcome
measure the effect of duration of untreated bipolar disorder on severity (young mania rating scale on admission
Time frame: one year
To study the effect of duration of untreated bipolar disorder (manic episodes) on clinical outcomes (severity).
1 secondary outcome
To measure the effect of duration of untreated bipolar disorder (manic episodes) on clinical outcomes (severity, residual symptoms, duration of admission).
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. i will share after finishing my research
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the effect of duration of untreated bipolar disorder on severity (young mania rating scale on admission (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.