A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT01202604
- Lead Sponsor
- AstraZeneca
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 294
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 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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 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)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the efficacy of mood stabilizers in NCT01202604 for bipolar I and II patients?
How does the observational study compare lithium versus anticonvulsants in preventing bipolar relapse in Greece?
Are there specific biomarkers identified in NCT01202604 that predict treatment response in bipolar disorder subtypes?
What adverse events were monitored in AstraZeneca's NCT01202604 trial for long-term bipolar maintenance therapy?
How do results from NCT01202604 inform the use of atypical antipsychotics in bipolar maintenance treatment?
Trial Locations
- Locations (1)
Research Site
🇬🇷Serres, Greece
Research Site🇬🇷Serres, Greece