Phase 3 N=298 Randomized Quadruple-blind Treatment

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Bipolar Disorder · Depression, Bipolar

Bottom Line

View on ClinicalTrials.gov: NCT00483548 ↗

Enrolled (actual)

298

Serious AEs

2.4%

Results posted

Feb 2010

Primary outcome: Primary: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -14.7; -13.2 scores on scale — p=0.7921

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ziprasidone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-14.7; -13.2	0.7921
SECONDARY Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)	-1.5; -1.5	0.7223
SECONDARY MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	48; 54	0.5029
SECONDARY MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	62; 65	0.8266
SECONDARY Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	66; 69	0.7924
SECONDARY Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)	-8.1; -6.1; -11.7; -9.0; -13.0; -11.0	0.0594
SECONDARY Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)	-0.5; -0.4; -0.9; -0.7; -0.9; -0.9	0.1771
SECONDARY CGI-Improvement Score	3.2; 3.4; 2.9; 3.1; 2.7; 2.9	0.0392 sig
SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score	-5.6; -5.9; -7.1; -7.4; -8.5; -8.6	0.6362
SECONDARY Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	0.7; -0.2; 0.5; -0.2; -0.0; -0.2	0.1277
SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6	14.7; 11.2; 0.0; 2.8	0.0108 sig
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)	-8.5; -3.7; 0.2; -1.4; -2.1; -1.6	0.0010 sig
SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)	-1.2; -0.7; 0.5; 0.0; -1.6; -1.3	0.1230
SECONDARY Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6	15.2; 11.6; -0.1; 1.6; 0.4; 0.3	0.5519

Summary

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Eligibility Criteria

Inclusion Criteria

Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion Criteria

Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
Psychotic symptoms (hallucinations and/or delusions).

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Data sourced from ClinicalTrials.gov (NCT00483548). 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.