NCT00483548

A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression

Completed Phase 3 Results posted Last updated 18 February 2021

What this trial tests

Phase 3 trial testing Ziprasidone in Bipolar Disorder in 298 participants. Completed in 1 December 2008.

Timeline

1 October 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	298
Start date	1 October 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	70 locations across United States, Australia, India

Drugs / interventions tested

• Ziprasidone (ziprasidone) — full drug profile →
• Placebo

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →
• Depression, Bipolar — all drugs for Depression, Bipolar →

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →

Who can join

18 and older, any sex, with Bipolar Disorder or Depression, Bipolar. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
  Time frame: Baseline, Week 6
  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); total score 0 to 44 (higher score indicates greater severi

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Genomic Dissection of Bipolar Disorder and Schizophrenia, Including 28 Subphenotypes.
   Bipolar Disorder and Schizophrenia Working Group of the Psychiatric Genomics Consortium. Electronic address: [e-mail], Bipolar Disorder and Schizophrenia Working Group of the Psychiatric Genomics Consortium. · · 2018 · cited 591× · PMID 29906448 · DOI 10.1016/j.cell.2018.05.046
2. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial.
   Sachs GS, Ice KS, Chappell PB, Schwartz JH, et al · · 2011 · cited 55× · PMID 21672493 · DOI 10.4088/jcp.09m05934
3. Refractoriness in bipolar disorder: definitions and evidence-based treatment.
   Fountoulakis KN. · · 2012 · cited 31× · PMID 22070611 · DOI 10.1111/j.1755-5949.2011.00259.x
4. Ziprasidone in the treatment of affective disorders: a review.
   Rosa AR, Franco C, Torrent C, Comes M, et al · · 2008 · cited 13× · PMID 19040553 · DOI 10.1111/j.1755-5949.2008.00056.x
5. Class effect of pharmacotherapy in bipolar disorder: fact or misbelief?
   Fountoulakis KN, Gonda X, Vieta E, Rihmer Z. · · 2011 · cited 12× · PMID 21435226 · DOI 10.1186/1744-859x-10-8