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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed) | During the first 9 months after the acute mood episode or in case of relapse occurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)]. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Panagiotis Pontikis | AstraZeneca S.A. Greece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aigio | Achaias | Greece | |||
| Research Site |
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| In all visits - during the whole study period (9 months) |
| YMRS total score, HAM-D total score | At baseline and final visit (9 months after the acute mood episode) |
| Ag. Paraskevi |
| Attikis |
| Greece |
| Research Site | Athens | Attikis | Greece |
| Research Site | Chaïdári | Attikis | Greece |
| Research Site | Drapetsona | Attikis | Greece |
| Research Site | Elefsina | Attikis | Greece |
| Research Site | Glyfada | Attikis | Greece |
| Research Site | Ilissia | Attikis | Greece |
| Research Site | Kifissia | Attikis | Greece |
| Research Site | Koropí | Attikis | Greece |
| Research Site | Marousi | Attikis | Greece |
| Research Site | N. Kosmos | Attikis | Greece |
| Research Site | Pangrati | Attikis | Greece |
| Research Site | Petroúpolis | Attikis | Greece |
| Research Site | Piraeus | Attikis | Greece |
| Research Site | Thebes | Attikis | Greece |
| Research Site | Vironas | Attikis | Greece |
| Research Site | Ag. Nikolaos | Crete | Greece |
| Research Site | Agrinio | Etoloakarnania | Greece |
| Research Site | Arta | Etoloakarnania | Greece |
| Research Site | Alexandroupoli | Evros | Greece |
| Research Site | Lamia | Fhiotidos | Greece |
| Research Site | Amaliáda | Ilias | Greece |
| Research Site | Karditsa | Karditsas | Greece |
| Research Site | Katerini | Katerinis | Greece |
| Research Site | Kavala | Kavalas | Greece |
| Research Site | Sparti | Lakonias | Greece |
| Research Site | Edessa | Pellas | Greece |
| Research Site | Giannitsá | Pellas | Greece |
| Research Site | Preveza | Prevezis | Greece |
| Research Site | Serres | Serres | Greece |
| Research Site | Thessaloniki | Thessalonikis | Greece |
| Research Site | Trikala | Trikalon | Greece |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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