Bipolar Disorder Clinical Trial
Official title:
Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.
Verified date | December 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
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).
Status | Completed |
Enrollment | 294 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis ?, 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Research Site | Ag. Nikolaos | Crete |
Greece | Research Site | Ag. Paraskevi | Attikis |
Greece | Research Site | Agrinio | Etoloakarnania |
Greece | Research Site | Aigio | Achaias |
Greece | Research Site | Alexandroupolis | Evros |
Greece | Research Site | Amaliada | Ilias |
Greece | Research Site | Arta | Etoloakarnania |
Greece | Research Site | Athens | Attikis |
Greece | Research Site | Chaidari | Attikis |
Greece | Research Site | Drapetsona | Attikis |
Greece | Research Site | Edessa | Pellas |
Greece | Research Site | Elefsina | Attikis |
Greece | Research Site | Giannitsa | Pellas |
Greece | Research Site | Glyfada | Attikis |
Greece | Research Site | Ilissia | Attikis |
Greece | Research Site | Karditsa | Karditsas |
Greece | Research Site | Katerini | Katerinis |
Greece | Research Site | Kavala | Kavalas |
Greece | Research Site | Kifisia | Attikis |
Greece | Research Site | Koropi | Attikis |
Greece | Research Site | Lamia | Fhiotidos |
Greece | Research Site | Maroussi | Attikis |
Greece | Research Site | N. Kosmos | Attikis |
Greece | Research Site | Pagrati | Attikis |
Greece | Research Site | Petroupoli | Attikis |
Greece | Research Site | Piraeus | Attikis |
Greece | Research Site | Preveza | Prevezis |
Greece | Research Site | Serres | |
Greece | Research Site | Sparti | Lakonias |
Greece | Research Site | Thessaloniki | Thessalonikis |
Greece | Research Site | Thiva | Attikis |
Greece | Research Site | Trikala | Trikalon |
Greece | Research Site | Vironas | Attikis |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | 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 | No | |
Secondary | Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase | In all visits - during the whole study period (9 months) | No | |
Secondary | YMRS total score, HAM-D total score | At baseline and final visit (9 months after the acute mood episode) | No |
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