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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
History of Changes
  Purpose

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.


Condition
Schizophrenia
Schizoaffective Disorder
Recurrent Depression

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Epidemiological Observational Non-interventional Study to Research the Prevalence of Bipolar Criteria of Hospital In-patients With Schizophrenia and Patients With Recurrent Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Enrollment: 750
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028196

Locations
Russian Federation
Research Site
Chita, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Novosibirsk, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Sergey N. Mosolov, Prof. Mental Disorders Moscow Research Institute of Psychiatry
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01028196     History of Changes
Other Study ID Numbers: NIS-NRU-DUM-2009/1
Study First Received: December 7, 2009
Last Updated: October 31, 2011
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
schizophrenia
schizoaffective disorder
recurrent depression
Bipolar disorders

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Psychotic Disorders
Schizophrenia
 Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 22, 2013