Phase 3
Completed N=296
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Source: ClinicalTrials.gov NCT01256177 ↗Enrolled (actual)
296
Serious AEs
1.0%
Results posted
Feb 2016
Primary outcomePrimary: Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -15.27; -18.48; 28.8; 28.5 Scores on a scale — p=0.004
Summary
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-15.27; -18.48; 28.8; 28.5 | 0.004 sig |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) |
62; 93 | 0.001 sig |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) |
59; 88 | 0.001 sig |
| SECONDARY Change From Baseline to Each Assessment in MADRS Total Score |
-4.14; -5.62; -7.70; -10.13; -11.05; -14.18 | 0.029 sig |
| SECONDARY Change From Baseline to Week 8 in HAM-D Total Scores |
-12.92; -15.16; 23.2; 23.5 | 0.007 sig |
| SECONDARY Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) |
-1.73; -2.24; -1.81; -2.28; 4.5; 4.6 | 0.003 sig |
| SECONDARY The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved |
65; 91 | 0.004 sig |
| SECONDARY Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation |
-0.76; -0.98; 1.2; 1.0 | 0.005 sig |
| SECONDARY Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) |
4; 1 | 0.233 |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Male and female patients, aged 18 to 65 years, inclusive.
- Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
- Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
- Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator
Exclusion Criteria
- Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
- Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and randomisation.
- Patients with >8 mood episodes during the past 12 months at enrolment.
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
- Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
- Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
- Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.
Data sourced from ClinicalTrials.gov (NCT01256177). 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.