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

Bipolar Disorder Clinical Trial

— Zip Ad  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293825
• Other study ID #: Pfizer IIR-WS883414
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2011
• Last updated: December 8, 2014
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Medication Adherence
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)	Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.	Week 16	No
Secondary	Treatment Adherence Score as Measured by the Morisky Rating Scale	Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.	Week 16	No
Secondary	Attitude Toward Medication Score as Measured by the Drug Attitude Inventory	Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.	Week 16	No
Secondary	Global Psychopathology Score as Measured by Clinical Global Impressions	Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.	Week 16	No
Secondary	Social and Occupational Functioning Scale	Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.	Week 16	No
Secondary	Montgomery Asberg Depression Rating Scale	Scale Range: 0-60. Lower scores indicate better outcomes.	Week 16	No
Secondary	Young Mania Rating Scale	Scale Range: 0-60. Lower scores indicate better outcomes.	Week 16	No
Secondary	Body Weight		Week 16	Yes
Secondary	Quality of Life Score as Measured by 12-item Short Form Health Survey	Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.	Week 16	No