A randomized, double-blind, placebo-controlled study of ziprasidone monotherapy
in bipolar disorder with co-occurring lifetime panic or generalized anxiety
disorder.
Author(s): Suppes T(1), McElroy SL, Sheehan DV, Hidalgo RB, Cosgrove VE, Gwizdowski IS,
Feldman NS.
Affiliation(s): Author information:
(1)VA Palo Alto Health Care System, 3801 Miranda Ave (151T), Palo Alto, CA 94304
tsuppes@stanford.edu.
Publication date & source: 2014, J Clin Psychiatry. , 75(1):77-84
OBJECTIVE: Bipolar disorder often co-occurs with anxiety disorders. Evidence
suggests that second-generation antipsychotics (SGAs) may be useful in treating
both conditions. This study examined the efficacy of ziprasidone in the treatment
of these disorders.
METHOD: This 3-site, randomized, double-blind, placebo-controlled, parallel
group, 8-week trial of ziprasidone monotherapy examined 49 subjects with bipolar
disorder and lifetime panic disorder (with or without agoraphobia) or generalized
anxiety disorder (GAD) experiencing moderately severe anxiety symptoms at
entrance into the study. Both bipolar disorder and anxiety diagnoses were based
on DSM-IV-TR criteria. Patients were screened and randomized from June 25, 2010,
through August 23, 2011. Primary outcome measures were the Clinical Global
Impressions-21 Anxiety Scale (CGI-21 Anxiety) and the Sheehan Disability Scale
(SDS), with secondary measures monitoring anxiety and mood symptoms.
RESULTS: Last-observation-carried-forward analyses demonstrated that patients in
the ziprasidone group did not improve significantly more than those in the
placebo group on the CGI-21 Anxiety (F1 = 0.34; P = .564) or SDS (F1 = 0.26; P =
.611). Secondary analysis using hierarchical linear modeling found similar
results (CGI-21 Anxiety: F1 = 1.82; P = .178; and SDS: F1 = 0.70; P = .408).
Regardless of group, time in the study was associated with significant decrease
in anxiety (F1 = 11.08; P = .001) and total disability (F1 = 26.16; P < .001).
Patients in the ziprasidone group showed a greater increase in abnormal
involuntary movement, and 81.8% (n = 9) of the subjects who withdrew from the
study due to adverse events, serious adverse events, or side effects were in the
ziprasidone group.
CONCLUSIONS: Results suggest that ziprasidone monotherapy was not associated with
a clinically significant improvement in anxiety symptoms or improved function for
patients with bipolar disorder, lifetime panic disorder or GAD, and concurrent
moderately severe anxiety symptoms, and it was associated with a more negative
side-effect profile relative to placebo.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01172652.
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