NCT01293825

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.

Conditions

• Medication Adherence
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	ziprasidone	Patients will identify which psychotropic they currently receive that causes the most weight-gain concern. For individuals on multiple drugs, one drug must be identified as the "offending agent". Study psychiatrist will switch the "offending agent" to ziprasidone. Participants will be switched to ziprasidone per package insert. Patients will be maintained on ziprasidone for 12 weeks (active part of study). After the active part of the study they will return to the care of their normal clinical provider who will determine whether they will continue on ziprasidone.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-02-11
• Last updated: 2014-12-30
• Results posted: 2014-04-22

Locations

1 site across 1 country: United States