Bipolar Disorder Clinical Trial
Official title:
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study
| Verified date | October 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Comité Ético de Investigación Clínica |
| Study type | Observational |
The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | October 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients diagnosed with bipolar disorder I or II DSM-IV - Patients treated with at least one oral antipsychotic - Subjects able to read and write Exclusion Criteria: - Patients participating in clinical trials |
Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Alicante | |
| Spain | Research Site | Almeria | |
| Spain | Research Site | Badajoz | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Calahorra | La Rioja |
| Spain | Research Site | Cordoba | |
| Spain | Research Site | Elche | |
| Spain | Research Site | La Laguna | Tenerife |
| Spain | Research Site | Langreo | Asturias |
| Spain | Research Site | Las Palmas | Gran Canarias |
| Spain | Research Site | Leon | |
| Spain | Research Site | Lerida | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | |
| Spain | Research Site | Murcia | |
| Spain | Research Site | Orense | |
| Spain | Research Site | Palma de Mallorca | |
| Spain | Research Site | Salamanca | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Toledo | |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Valladolid | |
| Spain | Research Site | Vitoria | |
| Spain | Research Site | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Morisky-Green Scale | Once, at the visit moment | No | |
| Primary | Drug Attitude Inventory Scale (DAI-10) | Once, at the visit moment | No | |
| Secondary | Clinical Global Impressions for Bipolar illness-modified (CGI-BP-M) | Once, at the visit moment | No | |
| Secondary | Functioning Assessment Short Test (FAST) | Once, at the visit moment | No |
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