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

NCT ID: NCT01293825

Last Updated: 2014-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medication Adherence Bipolar Disorder

There was only one group in this study. All participants received the study drug Ziprasidone.

Group Type: EXPERIMENTAL

ziprasidone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Geodon

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)

2. On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)

3. Have weight gain concerns that individual believes are related to BD medication treatment

4. Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the "offending agent" in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies

Exclusion Criteria

1. Known resistance or intolerance to ziprasidone

2. Medical contraindication to ziprasidone

3. Individuals on ziprasidone immediately prior to study enrollment

4. Prior or current treatment with clozapine

5. Diagnosis of eating disorder

6. Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits

7. Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial

8. Current substance dependence

9. High risk of harm to self or others

10. Female who is currently pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Martha Sajatovic

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Sajatovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

Pfizer IIR-WS883414

Identifier Type: -

Identifier Source: org_study_id