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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01028196
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):

Brief Summary:

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 or disease
Schizophrenia Schizoaffective Disorder Recurrent Depression

Study Type : Observational
Actual Enrollment : 750 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01028196

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

Responsible Party: AstraZeneca Identifier: NCT01028196     History of Changes
Other Study ID Numbers: NIS-NRU-DUM-2009/1
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by AstraZeneca:
schizoaffective disorder
recurrent depression
Bipolar disorders

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders