Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

Phase 4 Completed 49 enrolled VA Palo Alto Health Care System Lindner Center of HOPE · collab Pfizer · collab University of South Florida · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Timeline

Start: 2010-04
Primary completion: 2011-10
Completion: 2011-10

Outcome

Missed primary endpoint

paper did not improve significantly more than those in the placebo group on the CGI-21 Anxiety (F1 = 0.34; P = .564) PMID 24345758 ↗

paper or SDS (F1 = 0.26; P = .611). PMID 24345758 ↗

Publications

Suppes T, McElroy SL, Sheehan DV, Hidalgo RB, Cosgrove VE, Gwizdowski IS, Feldman NS. A randomized, double-blind, placebo-controlled study of ziprasidone monotherapy in bipolar disorder with co-occurring lifetime panic or generalized anxiety disorder. J Clin Psychiatry. 2014 Jan;75(1):77-84. doi: 10.4088/JCP.12m08297.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziprasidone	Small molecule	40 mg	—
Subject	Ziprasidone	Small molecule	80 mg	—
Subject	Ziprasidone	Small molecule	160 mg	—