3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
680
Placebo with mood stabilizer (either lithium or divalproex)
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)
YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).
Time frame: Baseline, Week 3
Change From Baseline to Week 1 and Week 2 in YMRS
YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).
Time frame: Baseline, Week 1, Week 2
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).
Time frame: Baseline, Week 1, Week 2, Week 3
Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score
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Dothan, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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Costa Mesa, California, United States
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Escondido, California, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
...and 56 more locations
CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).
Time frame: Baseline, Week 1, Week 2, Week 3
Clinical Global Impression - Improvement (CGI-I) Scale Scores
CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.
Time frame: Week 1, Week 2, Week 3
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score
PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).
Time frame: Baseline, Week 3
Change From Baseline in Global Assessment of Functioning (GAF) Score
GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).
Time frame: Baseline, Week 3
Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score
LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).
Time frame: Baseline, Week 3
Anonymized Pharmacogenomic Blood Draw
Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.
Time frame: Baseline