Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01028196
First received: December 7, 2009
Last updated: October 31, 2011
Last verified: October 2011

December 7, 2009
October 31, 2011
November 2009
November 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01028196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression
Epidemiological Observational Non-interventional Study to Research the Prevalence of Bipolar Criteria of Hospital In-patients With Schizophrenia and Patients With Recurrent Depression

This study is aimed to evaluate the bipolar disorder symptoms in patients presented with schizophrenia, schizoaffective disorder or recurrent depression.

Bipolar disorder is a group of mood disorders characterised by elevated or irritable mood episodes in patient's lifetime history accompanied by some additional symptoms. In this study modern bipolar disorders screening/assessment instruments will be used to explore the prevalence of bipolarity symptoms in patients who never been diagnosed with bipolar disorders. The results of this study could be useful for more accurate assessment of bipolar disorders prevalence in psychiatric patient population, could help to improve the diagnostics of bipolar disorders and management of bipolar patients.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients having current diagnosis of schizophrenia/ schizoaffective disorder (in-patients) and patients having current diagnosis of recurrent depression (both in-patients and out-patients) will be included into this study.

  • Schizophrenia
  • Schizoaffective Disorder
  • Recurrent Depression
Not Provided
  • 1 - schizophrenia
    Psychiatrists will enrol patients meeting inclusion/exclusion criteria with schizophrenia as they routinely attend the clinic or are examined in hospital in a consecutively manner.
  • 2 - recurrent depression
    Psychiatrists will enrol patients meeting inclusion/exclusion criteria with recurrent depression as they routinely attend the clinic or are examined in hospital in a consecutively manner.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • signed patient informed consent
  • In-patients with the diagnosis of schizophrenia with episodic course or schizoaffective disorder, OR in-patients and out-patients with the diagnosis of recurrent depression.
  • The duration of the disease is 3 years and longer and two or more episodes of the disease in the patients history.

Exclusion Criteria:

  • Current diagnosis of Bipolar Disorder
  • Severe and unspecified forms of schizophrenia (schizophrenia with continuous course, hebephrenic schizophrenia, catatonic schizophrenia, undifferentiated schizophrenia, unspecified schizophrenia) and organic affective disorder or intoxication induced affective disorder.
  • Any other concomitant conditions which, in the judgment of investigator, will not allow the patient to complete the study procedures
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01028196
NIS-NRU-DUM-2009/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Sergey N. Mosolov, Prof. Mental Disorders Moscow Research Institute of Psychiatry
AstraZeneca
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP