Bipolar DisorderSEQUELNCT00533260
A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)
An observational study of Bipolar Disorder and Schizophrenia, run by AstraZeneca at 35 sites in Netherlands.
Trial summary
The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- How many people
- 128 participants
- Where
- 35 sitesNetherlands
- Study dates
- Jul 2007to Apr 2008
- 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: The patients who were considered for participation were patients who were being treated with quetiapine according to the Core Data Sheet and who were on a stable dosing regime. They could have been patients with schizophrenia or patients experiencing a manic episode associated with a bipolar disorder. Quetiapine was administered to the patients in regular practice.
Who may be able to join
- The subjects should be considered eligible for this trail according to the physician:
- Patients with a diagnose of schizophrenia or bipolar disorder with a recent manic episode
- Patients who are being treated with quetiapine and are on an effective dose according to the Core Data Sheet; for schizophrenia between 300 and 450 mg (maximum 750 mg) and bipolar disorder between 400 and 800 mg.
- Patients who consent to make the coded data available to AstraZeneca; provision of written informed consent
- Considered eligible for this study and able to understand and comply with the requirements of the study according to the physician
- In possession of a private mobile phone and capable of using this mobile phone to send SMS text messages
Who cannot join
- Subjects who, in the opinion of the Physician, pose an imminent risk of suicide or a danger to themselves or others are excluded from the trial.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Netherlands35 sites
Research Site
Almelo
Research Site
Alphen Aan de Rigjn
Research Site
Amersfoort
Research Site
Amstelveen
Research Site
Arnhem
Research Site
Bennebroek
Research Site
Beverwijk
Research Site
Bosch en Duin
Research Site
Brummen
Research Site
Brunssum
Research Site
Doetichem
Research Site
Druten
Research Site
Ede
Research Site
Groningen
Research Site
Haarlem
Research Site
Heerde
Research Site
Helmond
Research Site
Hoofddorp
Research Site
IJmuiden
Research Site
Leeuwarden
Research Site
Maastricht
Research Site
Nijbroek
Research Site
Nijmegen
Research Site
Oegstgeest
Research Site
Raalte
Research Site
Roermond
Research Site
Schagen
Research Site
Steenwijk
Research Site
Tiel
Research Site
Tilburg
Research Site
Venray
Research Site
Vlaardingen
Research Site
Voorhout
Research Site
Weert
Research Site
Wolfheze
About this study
Official title: A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel®
The basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the feasibility of using SMS technology within normal clinical practice in The Netherlands.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime
- Medical subject headings
- Bipolar Disorder, Schizophrenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- N van Schayk, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533260
- Sponsor's protocol ID
- NIS-NNL-SER-2007/1
- Acronym
- SEQUEL
- Status last verified
- Dec 2010
- First submitted
- 20 Sep 2007
- Last updated
- 9 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel®
- ClinicalTrials.gov ID
- NCT00533260
- Acronym / sponsor ID
- SEQUEL / NIS-NNL-SER-2007/1
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- Patients with a manic episode or patients diagnosed with schizophrenia , patients who are being treated with quetiapine and are on a stable dosing regime
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Sep 2007 (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 basic hypothesis of this trial is that forgetfulness and failure to establish a routine that facilitates medication adherence are prominent reasons for non-adherence. Daily use of the SMS text messages is designed to enhance patient adherence with medication by promoting daily routine and demonstrate the feasibility of using SMS technology within normal clinical practice in The Netherlands.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were considered for participation were patients who were being treated with quetiapine according to the Core Data Sheet and who were on a stable dosing regime. They could have been patients with schizophrenia or patients experiencing a manic episode associated with a bipolar disorder. Quetiapine was administered to the patients in regular practice.
Key inclusion criteria (6 listed)
- The subjects should be considered eligible for this trail according to the physician:
Key exclusion criteria (1 listed)
- Subjects who, in the opinion of the Physician, pose an imminent risk of suicide or a danger to themselves or others are excluded from the trial.
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 9 Dec 2010.
Related trials for Bipolar Disorder
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)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
N van Schayk study director
AstraZeneca
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Schizophrenia, run by AstraZeneca at 35 sites in Netherlands.
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 6 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 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Netherlands. 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 9 Dec 2010.