Bipolar DisorderMM1NCT00690248
Depressive Symptoms in Acute Manic Episode
An observational study of Bipolar Disorder, run by AstraZeneca at 34 sites in Spain.
Trial summary
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 250 participants
- Where
- 34 sitesSpain
- Study dates
- Nov 2007to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
Who may be able to join
- Diagnosed of Bipolar Disorder based on DSM-IV-TR
- Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV_TR)
- Provision of written informed consent.
- Total score in Young Mania Rating Scale >=20
- Able to understand and comply with the requirements of the study
Who cannot join
- Mental retardation
- Patients with manic symptoms are due to substance use, based in the investigator opinion
- Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion.
- Participation in a trial with drugs within 4 weeks of enrolment into this study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Spain34 sites
Research Site
A Coruña
Research Site
Alcoy
Research Site
Algeciras
Research Site
Almería
Research Site
Barcelona
Research Site
Burgos
Research Site
Córdoba
Research Site
Granada
Research Site
Las Palmas
Research Site
Logroño
Research Site
Madrid
Research Site
Málaga
Research Site
Murcia
Research Site
Osuna
Research Site
Oviedo
Research Site
Palma de Mallorca
Research Site
Pamplona
Research Site
Plasencia
Research Site
Ponferrada
Research Site
Pontevedra
Research Site
Salamanca
Research Site
San Juan (Alicante)
Research Site
Sant Boi de Llobregat
Research Site
Santa Cruz de Tenerife
Research Site
Santander
Research Site
Santiago de Compostela
Research Site
Seville
Research Site
Teruel
Research Site
Toledo
Research Site
Valencia
Research Site
Valladolid
Research Site
Vitoria-Gasteiz
Research Site
Zamora
Research Site
Zaragoza
About this study
Official title: Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania
- Conditions
- Bipolar Disorder
- Keywords
- Acute mania, Bipolar disorder, depressive symptoms, mixed mania
- Medical subject headings
- Bipolar Disorder, Depression
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 | Bipolar patients admitted to a psychiatric Unit due to an acute mania episode. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
Measured: once during study
Secondary outcomes (7)
Mania symptoms measured with YMRS (Young Mania Rating Scale).
Measured: once during study
Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).
Measured: once during study
Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).
Measured: once during study
Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).
Measured: once during study
Days of hospitalization, MADRS (6 items)
Measured: once during study
Hamilton Depression Rating Scale (5 items)
Measured: once during study
Scale of Unawareness of Mental Disorders (SUMD)
Measured: once during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionDec 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690248
- Sponsor's protocol ID
- NIS-NES-DUM-2007/5
- Acronym
- MM1
- Status last verified
- Dec 2010
- First submitted
- 2 Jun 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- 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
- Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT00690248
- Acronym / sponsor ID
- MM1 / NIS-NES-DUM-2007/5
- Conditions
- Bipolar Disorder
- Keywords
- Acute mania, Bipolar disorder, depressive symptoms, mixed mania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jun 2008 (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.
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Bipolar patients admitted to a psychiatric Unit due to an acute mania episode. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
Key inclusion criteria (5 listed)
- Diagnosed of Bipolar Disorder based on DSM-IV-TR
- Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV_TR)
- Provision of written informed consent.
- Total score in Young Mania Rating Scale >=20
- Able to understand and comply with the requirements of the study
Key exclusion criteria (4 listed)
- Mental retardation
- Patients with manic symptoms are due to substance use, based in the investigator opinion
- Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion.
- Participation in a trial with drugs within 4 weeks of enrolment into this study.
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
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
Time frame: once during study
7 secondary outcomes
Mania symptoms measured with YMRS (Young Mania Rating Scale).
Time frame: once during study
Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).
Time frame: once during study
Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).
Time frame: once during study
Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).
Time frame: once during study
Days of hospitalization, MADRS (6 items)
Time frame: once during study
Hamilton Depression Rating Scale (5 items)
Time frame: once during study
Scale of Unawareness of Mental Disorders (SUMD)
Time frame: once during study
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 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 34 sites in Spain.
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 5 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 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 34 sites in Spain. 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?
Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania. (time frame: once during study). 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 9 Dec 2010.