- Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2 [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
- Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
- Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).
- Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs [ Time Frame: Throughout Phase 2 (up to 52 weeks) ] [ Designated as safety issue: Yes ]
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
- Adjusted Mean Change From Baseline in Body Weight, Phase 2 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: Yes ]
Adjusted for index mood episode and baseline assessment
- Number of Participants Showing Clinically Relevant Weight Loss by Study Week [ Time Frame: Weeks 12, 24, 36, 52 ] [ Designated as safety issue: Yes ]
Weight Loss of at least a 7% decrease from Baseline.
- Number of Participants Showing Clinically Relevant Weight Gain by Study Week [ Time Frame: Weeks 12, 24, 36, 52 ] [ Designated as safety issue: Yes ]
Weight gain of at least a 7% increase from Baseline.
- Adjusted Mean Change From Baseline in BMI by Study Week [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ] [ Designated as safety issue: Yes ]
Adjusted for index mood episode and baseline assessment.
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment [ Time Frame: Throughout the study, up to Week 52 ] [ Designated as safety issue: Yes ]
Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.
- Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment [ Time Frame: Up to 52 Weeks ] [ Designated as safety issue: Yes ]
In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.
- Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2) [ Time Frame: Throughout Phase 2 of the study, up to Week 52 ] [ Designated as safety issue: Yes ]
Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)
- Summary of Concomitant Medications, Phase 1 [ Time Frame: Phase 1 (9 to 24 Week Single-blind Stabilization Phase) ] [ Designated as safety issue: Yes ]
- Summary of Concomitant Medications, Phase 2 [ Time Frame: Phase 2 (52 Week Double-blind Relapse Assessment Phase) ] [ Designated as safety issue: Yes ]
- Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ] [ Designated as safety issue: Yes ]
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.
- Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ] [ Designated as safety issue: Yes ]
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
- Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment, [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ] [ Designated as safety issue: Yes ]
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Purpose
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