Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary

An observational study of Schizophrenia and Affective Symptoms, run by AstraZeneca at 53 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia, Affective Symptoms
How many people: 2,153 participants
Where: 53 sitesHungary
Study dates: Feb 2012to Dec 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Schizophrenic outpatients above 18 years of age with affective symptoms.

Who may be able to join

Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms.
Atypical antipsychotic treatment at least for a month before study inclusion.

Who cannot join

Pregnancy.
Hepatic disease.
Diabetes mellitus.
Severe cerebro- or cardiovascular disease.

Trial locations and contacts

53 sites in 1 country.

City, postcode or hospital

53 sites in 1 country

Hungary53 sites

Research Site
Agárd
Research Site
Baja
Research Site
Barcs
Research Site
Berettyóújfalu
Research Site
Bicske
Research Site
Bonyhád
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Dombóvár
Research Site
Dunaújváros
Research Site
Érd
Research Site
Esztergom
Research Site
Gyöngyös
Research Site
Győr
Research Site
Gyula
Research Site
Hatvan
Research Site
Heves
Research Site
Hódmezővásárhely
Research Site
Izsófalva
Research Site
Jánoshalma
Research Site
Jászberény
Research Site
Kalocsa
Research Site
Karcag
Research Site
Kecskemét
Research Site
Kiskunhalas
Research Site
Kiskunmajsa
Research Site
Kistarcsa
Research Site
Kistokaj
Research Site
Makó
Research Site
Miskolc
Research Site
Mosonmagyaróvár
Research Site
Nagykálló
Research Site
Nagykanizsa
Research Site
Oroszlány
Research Site
Pápa
Research Site
Pécs
Research Site
Pomáz
Research Site
Salgótarján
Research Site
Sátoraljaújhely
Research Site
Sopron
Research Site
Szeged
Research Site
Szeghalom
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szentendre
Research Site
Szentes
Research Site
Szigetszentmiklós
Research Site
Szolnok
Research Site
Szombathely
Research Site
Tószeg
Research Site
Vác
Research Site
Veszprém

Other trials in Hungary

About this study

Official title: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.

This is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.

Read the detailed description

Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Conditions: Schizophrenia, Affective Symptoms
Keywords: schizophrenia, atypical antipsychotics, depressive symptoms
Medical subject headings: Schizophrenia, Affective Symptoms, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01534936
Study group	Role	What they receive
Schizophrenic outpatients with affective symptoms.		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.
The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). "0" stands for "not assessed". Means and standard deviations (SD) for CGI-S(baseline), CGI-S (1.visit) CGI-S (2.visit) and for CGI-I will be calculated.
Measured: 3 and 6 months

Secondary outcomes (3)

Description of the relation between and the change of affective symptoms and overall clinical status.
Measured: 3 and 6 months
Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in CGI-S (CGI severity of illness measure) and CGI-I (CGI global improvement measure).
The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). "0" stands for "not assessed".
Measured: From baseline up to 6 months
Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale.
Raskin scale is rated from 1 not at all to 5 very much , in three aspects: verbal report, behaviour, secondary symptoms of depression. Above 9 (the sum points) is considered moderate depression.
Measured: From baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Dec 2012

First posted17 Feb 2012 (estimated)
Study startFeb 2012
Primary completionDec 2012
Study completionDec 2012

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: Cohort
Time perspective: Prospective
Enrolment: 2,153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01534936
Sponsor's protocol ID: NIS-NHU-ATC-2011/1
Acronym: AFFECT
Status last verified: Dec 2012
First submitted: 13 Feb 2012
Last updated: 20 Dec 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.
ClinicalTrials.gov ID: NCT01534936
Acronym / sponsor ID: AFFECT / NIS-NHU-ATC-2011/1
Conditions: Schizophrenia, Affective Symptoms
Keywords: schizophrenia, atypical antipsychotics, depressive symptoms
Study type: Observational
Recruitment status: Completed
Enrolment: 2,153 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 17 Feb 2012 (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 is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.

Detailed description

Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Schizophrenic outpatients with affective symptoms.	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Schizophrenic outpatients above 18 years of age with affective symptoms.

Key inclusion criteria (2 listed)

Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms.
Atypical antipsychotic treatment at least for a month before study inclusion.

Key exclusion criteria (4 listed)

Pregnancy.
Hepatic disease.
Diabetes mellitus.
Severe cerebro- or cardiovascular disease.

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

Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.
Time frame: 3 and 6 months
The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). "0" stands for "not assessed". Means and standard deviations (SD) for CGI-S(baseline), CGI-S (1.visit) CGI-S (2.visit) and for CGI-I will be calculated.

3 secondary outcomes

Description of the relation between and the change of affective symptoms and overall clinical status.
Time frame: 3 and 6 months
Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in CGI-S (CGI severity of illness measure) and CGI-I (CGI global improvement measure).
Time frame: From baseline up to 6 months
Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale.
Time frame: From baseline up to 6 months

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 20 Dec 2012.

Related trials for Schizophrenia

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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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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.

Attila Nemeth, MD PHD principal investigator

National Center of Psychiatry

Lilla Szabo, MD study chair

AstraZeneca

Alexandra Heringh, MD study director

AstraZeneca

53 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 Affective Symptoms, run by AstraZeneca at 53 sites in Hungary.

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 2 inclusion and 4 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 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Hungary. 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.

What does the primary outcome measure?

Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms. (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534936.

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 20 Dec 2012.