Phase 4
Completed N=88
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
Bipolar Disorder · Bipolar Affective Psychosis · Mania · Manic Disorder
Source: ClinicalTrials.gov NCT00521365 ↗
Enrolled (actual)
88
Serious AEs
1.1%
Results posted
Jul 2012
Primary outcomePrimary: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) — -20.72 Scores on a scale
Summary
The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) |
-20.72 | — |
| SECONDARY Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. |
-11.5 | — |
| SECONDARY Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3 |
-18.01 | — |
| SECONDARY Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF) |
81 | — |
| SECONDARY Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF). |
49 | — |
| SECONDARY Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I). |
-3.95 | — |
| SECONDARY Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF). |
1.67 | — |
| SECONDARY Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study. |
0.31 | — |
| SECONDARY Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF). |
27.73 | — |
| SECONDARY Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). |
1.16 | — |
| SECONDARY Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). |
1.78 | — |
| SECONDARY Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF). |
0.27 | — |
| SECONDARY Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF). |
-0.29 | — |
| SECONDARY Number of Participants With >7% Increase in Weight |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
- Patients of both genders, aged 18-65 years old being at the first episode
- Patients with chronic Bipolar Disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality
Exclusion Criteria
- Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
Data sourced from ClinicalTrials.gov (NCT00521365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.