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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01293825
First received: February 10, 2011
Last updated: March 19, 2014
Last verified: March 2014

February 10, 2011
March 19, 2014
January 2011
August 2012   (final data collection date for primary outcome measure)
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
Treatment non-adherence percentage as measured by the Tablet Routines Questionnaire (TRQ) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Scale Range: 0-100%
Complete list of historical versions of study NCT01293825 on ClinicalTrials.gov Archive Site
  • Treatment Adherence Score as Measured by the Morisky Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
  • Attitude Toward Medication Score as Measured by the Drug Attitude Inventory [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
  • Global Psychopathology Score as Measured by Clinical Global Impressions [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.
  • Social and Occupational Functioning Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.
  • Montgomery Asberg Depression Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60. Lower scores indicate better outcomes.
  • Young Mania Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60. Lower scores indicate better outcomes.
  • Body Weight [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Quality of Life Score as Measured by 12-item Short Form Health Survey [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
  • Treatment adherence score as measured by the Morisky Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-4
  • Attitude toward medication score as measured by the Drug Attitude Inventory [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-10
  • Global psychopathology score as measured by Clinical Global Impressions [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 1-7
  • Social and Occupational Functioning Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-100
  • Montgomery Asberg Depression Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60
  • Young Mania Rating Scale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 0-60
  • body weight [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Laboratory testing [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    baseline electrolytes, renal function, thyroid function, liver function tests, lipid profile and CBC with differential, B12/folate
  • 12-lead EKG [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Quality of life score as measured by 12-item Short Form Health Survey [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Scale Range: 1-99th percentile score
  • Blood Pressure [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Height [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Medication Adherence
  • Bipolar Disorder
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.
Other Name: Geodon
Experimental: Medication Adherence Bipolar Disorder
There was only one group in this study. All participants received the study drug Ziprasidone.
Intervention: Drug: ziprasidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01293825
Pfizer IIR-WS883414
Yes
Martha Sajatovic, University Hospitals of Cleveland
University Hospitals of Cleveland
Pfizer
Principal Investigator: Martha Sajatovic, M.D. Case Western Reserve University School of Medicine
University Hospitals of Cleveland
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP