Last updated: 01/09/2019 17:00:33
Prevalence and characteristic of bipolar disorders and major depression in patients with a major depressive episode in Japan.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Prevalence and characteristic of bipolar disorders and major depression in patients with a major depressive episode in Japan.
Trial description: 16% patients with a major depressive episode were bipolar disorders in abroad. But no such prevalence data are available in Japanese patients. The symptoms of bipolar depression are similar to the symptoms of unipolar depression, but the treatment for bipolar disorders is very different from the one for unipolar disorders. Proper diagnosis of bipolar disorders would be very important for providing the best treatment options. We investigate the rate of bipolar disorders and unipolar disorders in patients with a major depressive episode in Japan, and identify the variables associated with bipolar disorders or unipolar disorders.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence rates of bipolar disorder and MDD in Japanese subjects with a major depressive episode
Timeframe: 1st visit
Analysis of factors associated with bipolar disorder
Timeframe: 1st visit
Analysis of factors associated with MDD
Timeframe: 1st visit
Analysis of factors affecting QOL in subjects with bipolar disorder and those with MDD
Timeframe: 1st visit
Analysis of factors affecting suicidal ideation in subjects with bipolar disorder and those with MDD
Timeframe: 1st visit
Prevalence rate of concurrent anxiety disorder in subjects with bipolar disorder and those with MDD
Timeframe: 1st visit
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
600
Primary completion date:
2017-22-12
Observational study model:
Case-Only
Time perspective:
Cross-sectional
Clinical publications:
Not applicable
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
April 2013 to December 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20Years - 65Years
Accepts healthy volunteers
None
- 1.Age: 20 to 65 years
- 2.Outpatients
- 1.A diagnosis of any of “schizophrenia and other cognitive disorders” based on the DSM-IV-TR criteria
- 2. A diagnosis of any of “physical disorder induced mood disorder” or “substance induced mood disorder” based on the DSM-IV-TR criteria
Inclusion and exclusion criteria
Inclusion criteria:
- 1.Age: 20 to 65 years 2.Outpatients 3.With a major depressive episode based on the DSM-IV-TR criteria
Exclusion criteria:
- 1.A diagnosis of any of “schizophrenia and other cognitive disorders” based on the DSM-IV-TR criteria 2. A diagnosis of any of “physical disorder induced mood disorder” or “substance induced mood disorder” based on the DSM-IV-TR criteria 3.Immediate risk of suicide attempt (judged by the attending physician) 4.Prior participation in this study 5.Any other reason the investigator (physician) deems the subject to be unsuitable for the study.
Trial location(s)
Showing 1 - 6 of 10 Results
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2017-22-12
Actual study completion date
2017-22-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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