Bipolar DisorderNCT01202604
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
An observational study of Bipolar Disorder, run by AstraZeneca at 33 sites in Greece.
Trial summary
The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 294 participants
- Where
- 33 sitesGreece
- Study dates
- Sep 2010to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients diagnosed with bipolar disorder I or II (as per DSM-IV), who have received therapy with at least one atypical antipsychotic for the acute episode and whose treating physician has considered they have entered the maintenance phase.
Who may be able to join
- Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks
- Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling
- Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication
- Provision of informed consent prior to study participation
Who cannot join
- Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- Subjects who have received treatment with a depot
- Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria
- Inability of subjects to comply with the study protocol.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Greece33 sites
Research Site
Ag. Nikolaos, Crete
Research Site
Ag. Paraskevi, Attikis
Research Site
Agrinio, Etoloakarnania
Research Site
Aigio, Achaias
Research Site
Alexandroupoli, Evros
Research Site
Amaliáda, Ilias
Research Site
Arta, Etoloakarnania
Research Site
Athens, Attikis
Research Site
Chaïdári, Attikis
Research Site
Drapetsona, Attikis
Research Site
Edessa, Pellas
Research Site
Elefsina, Attikis
Research Site
Giannitsá, Pellas
Research Site
Glyfada, Attikis
Research Site
Ilissia, Attikis
Research Site
Karditsa, Karditsas
Research Site
Katerini, Katerinis
Research Site
Kavala, Kavalas
Research Site
Kifissia, Attikis
Research Site
Koropí, Attikis
Research Site
Lamia, Fhiotidos
Research Site
Marousi, Attikis
Research Site
N. Kosmos, Attikis
Research Site
Pangrati, Attikis
Research Site
Petroúpolis, Attikis
Research Site
Piraeus, Attikis
Research Site
Preveza, Prevezis
Research Site
Serres, Serres
Research Site
Sparti, Lakonias
Research Site
Thebes, Attikis
Research Site
Thessaloniki, Thessalonikis
Research Site
Trikala, Trikalon
Research Site
Vironas, Attikis
About this study
Official title: Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.
The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder I and II, mood event, manic or depressive, Greece
- Medical subject headings
- Bipolar Disorder, Mania
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 |
|---|---|---|
| Outpatients with bipolar disorder I or II (as per DSM-IV) | The percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)
Measured: During the first 9 months after the acute mood episode or in case of relapse occurrence.
Secondary outcomes (3)
Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].
Measured: 4 months and 9 months after the acute mood episode or in case of relapse occurrence
Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase
Measured: In all visits - during the whole study period (9 months)
YMRS total score, HAM-D total score
Measured: At baseline and final visit (9 months after the acute mood episode)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Panagiotis Pontikis, Study director, AstraZeneca S.A. Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202604
- Sponsor's protocol ID
- NIS-NGR-DUM-2010/1
- Status last verified
- Dec 2011
- First submitted
- 14 Sep 2010
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.
- ClinicalTrials.gov ID
- NCT01202604
- Acronym / sponsor ID
- NIS-NGR-DUM-2010/1
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder I and II, mood event, manic or depressive, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 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 primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients with bipolar disorder I or II (as per DSM-IV) | – | –The percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients diagnosed with bipolar disorder I or II (as per DSM-IV), who have received therapy with at least one atypical antipsychotic for the acute episode and whose treating physician has considered they have entered the maintenance phase.
Key inclusion criteria (4 listed)
- Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks
- Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling
- Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication
- Provision of informed consent prior to study participation
Key exclusion criteria (4 listed)
- Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- Subjects who have received treatment with a depot
- Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria
- Inability of subjects to comply with the study protocol.
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
The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)
Time frame: During the first 9 months after the acute mood episode or in case of relapse occurrence.
3 secondary outcomes
Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].
Time frame: 4 months and 9 months after the acute mood episode or in case of relapse occurrence
Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase
Time frame: In all visits - during the whole study period (9 months)
YMRS total score, HAM-D total score
Time frame: At baseline and final visit (9 months after the acute mood episode)
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 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.
Dr. Panagiotis Pontikis study director
AstraZeneca S.A. Greece
33 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, run by AstraZeneca at 33 sites in Greece.
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 4 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 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Greece. 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?
The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed) (time frame: During the first 9 months after the acute mood episode or in case of relapse occurrence.). It is what the study was designed to measure, not a finding.
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 20 Dec 2011.