SchizophreniaNCT01028196
Observational Study to Evaluate Bipolar Disorder Symptoms in Patients Presented With Schizophrenia or Depression
An observational study of Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 3 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Recurrent Depression
- How many people
- 750 participants
- Where
- 3 sitesRussia
- Study dates
- Nov 2009to Nov 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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
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.
- Keywords
- schizophrenia, schizoaffective disorder, recurrent depression, Bipolar disorders
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey N. Mosolov, Prof., Principal investigator, Mental Disorders Moscow Research Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028196
- Sponsor's protocol ID
- NIS-NRU-DUM-2009/1
- Status last verified
- Oct 2011
- First submitted
- 7 Dec 2009
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01028196
- Acronym / sponsor ID
- NIS-NRU-DUM-2009/1
- Keywords
- schizophrenia, schizoaffective disorder, recurrent depression, Bipolar disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Dec 2009 (estimated)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
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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.
Sergey N. Mosolov, Prof. principal investigator
Mental Disorders Moscow Research Institute of Psychiatry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 3 sites in Russia.
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: finished, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 1 Nov 2011.