Relapse in SchizophreniaSereNISNCT01202617

Seroquel XR in the Long Term Treatment of Schizophrenia

An observational study of Relapse in Schizophrenia, run by AstraZeneca at 61 sites in Hungary.

Completed

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

Trial summary

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improves the relapse prevention in schizophrenic outpatients Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Relapse in Schizophrenia
How many people: 1,606 participants
Where: 61 sitesHungary
Study dates: Sep 2010to Oct 2011
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Psychiatric outpatients

Who may be able to join

schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Who cannot join

Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

Trial locations and contacts

61 sites in 1 country.

City, postcode or hospital

61 sites in 1 country

Hungary61 sites

Research Site
Baja
Research Site
Balassagyarmat
Research Site
Barcs
Research Site
Berettyóújfalu
Research Site
Budapest
Research Site
Cegléd
Research Site
Csongrád
Research Site
Debrecen
Research Site
Dombóvár
Research Site
Dunaújváros
Research Site
Eger
Research Site
Emőd
Research Site
Érd
Research Site
Esztergom
Research Site
Gödöllő
Research Site
Gyöngyös
Research Site
Győr
Research Site
Gyula
Research Site
Hajdusamson-Martinka
Research Site
Hajdúszoboszló
Research Site
Heves
Research Site
Jánoshalma
Research Site
Jászberény
Research Site
Kalocsa
Research Site
Karcag
Research Site
Kecskemét
Research Site
Kétegyháza
Research Site
Kiskunhalas
Research Site
Kiskunmajsa
Research Site
Kistarcsa
Research Site
Kistokaj
Research Site
Komárom
Research Site
Kozármisleny
Research Site
Miskolc
Research Site
Nagyatád
Research Site
Nagykálló
Research Site
Nagykanizsa
Research Site
Nagykőrös
Research Site
Ny�regyhaza
Research Site
Pécs
Research Site
Pomáz
Research Site
Salgótarján
Research Site
Sátoraljaújhely
Research Site
Soltvadkert
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
Szigetvár
Research Site
Szolnok
Research Site
Szombathely
Research Site
Tata
Research Site
Tatabánya
Research Site
Tószeg
Research Site
Vác
Research Site
Veszprém
Research Site
Zalegerszeg

Other trials in Hungary

About this study

Official title: Seroquel XR in the Long Term Treatment of Schizophrenia Focus on Affective Symptoms

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improves the relapse prevention in schizophrenic outpatients

Conditions: Relapse in Schizophrenia
Keywords: Seroquel XR, schizophrenia, relapse prevention
Medical subject headings: Schizophrenia

What participants receive

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

Study groups in NCT01202617
Study group	Role	What they receive
Schizophrenic outpatients between 18 & 70 years of age		Not described

What is being measured

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

Rate of patients remained relapse free after 6 months of treatment
Measured: on the 60th day of treatment
Rate of patients remained relapse free after 6 months of treatment
Measured: on the 180th day of treatment

Secondary outcomes (2)

connection between relapse and affective symptoms
Measured: on the 60th day of treatment
connection between relapse and affective symptoms
Measured: 180th day of treatment

Timeline

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

Sep 2010Oct 2011

First posted16 Sep 2010 (estimated)
Study startSep 2010
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapse in 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: 1,606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01202617
Sponsor's protocol ID: NIS-NHU-SER-2010/1
Acronym: SereNIS
Status last verified: Oct 2011
First submitted: 14 Sep 2010
Last updated: 24 Oct 2011
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

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)
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
RecruitingPhase 3
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
Schizophrenia
Recruiting
Voice-Based Biomarkers: A Novel Approach to Monitoring and Predicting Schizophrenia Relapses
Schizophrenia

All Relapse in Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Seroquel XR in the Long Term Treatment of Schizophrenia Focus on Affective Symptoms
ClinicalTrials.gov ID: NCT01202617
Acronym / sponsor ID: SereNIS / NIS-NHU-SER-2010/1
Conditions: Relapse in Schizophrenia
Keywords: Seroquel XR, schizophrenia, relapse prevention
Study type: Observational
Recruitment status: Completed
Enrolment: 1,606 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 16 Sep 2010 (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.

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improves the relapse prevention in schizophrenic outpatients

Study design

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

Arm	Type	Receives
Schizophrenic outpatients between 18 & 70 years of age	–	–

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Psychiatric outpatients

Key inclusion criteria (1 listed)

schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Key exclusion criteria (1 listed)

Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

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

Rate of patients remained relapse free after 6 months of treatment
Time frame: on the 60th day of treatment
Rate of patients remained relapse free after 6 months of treatment
Time frame: on the 180th day of treatment

2 secondary outcomes

connection between relapse and affective symptoms
Time frame: on the 60th day of treatment
connection between relapse and affective symptoms
Time frame: 180th day of treatment

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 24 Oct 2011.

Related trials for Relapse in Schizophrenia

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)
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
RecruitingPhase 3
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
Schizophrenia
Recruiting
Voice-Based Biomarkers: A Novel Approach to Monitoring and Predicting Schizophrenia Relapses
Schizophrenia

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 principal investigator

National Psychiatric Centre

Lilla Szabo study chair

AstraZeneca

Alexandra Henringh study director

AstraZeneca

61 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Relapse in Schizophrenia, run by AstraZeneca at 61 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 1 inclusion and 1 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 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 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?

Rate of patients remained relapse free after 6 months of treatment (time frame: on the 60th day of treatment). The study lists 2 primary outcomes in all. 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 NCT01202617.

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 24 Oct 2011; AzTrials last refreshed its copy on 8 Nov 2026.