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NCT Number: NCT01293825

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

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.

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Key information

Conditions

Medication Adherence Behavior Bipolar Disorder Bipolar and Related Disorders Health Behavior Mental Disorders Mood Disorders Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)
  • On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)
  • Have weight gain concerns that individual believes are related to BD medication treatment
  • 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

  • Known resistance or intolerance to ziprasidone
  • Medical contraindication to ziprasidone
  • Individuals on ziprasidone immediately prior to study enrollment
  • Prior or current treatment with clozapine
  • Diagnosis of eating disorder
  • 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
  • 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
  • Current substance dependence
  • High risk of harm to self or others
  • Female who is currently pregnant or breastfeeding

Treatment and study plan

Ziprasidone

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.

Other names: Geodon

Primary outcomes

  1. Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)

    Time frame: Week 16

    Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.

Secondary outcomes

  1. Treatment Adherence Score as Measured by the Morisky Rating Scale

    Time frame: Week 16

    Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.

  2. Attitude Toward Medication Score as Measured by the Drug Attitude Inventory

    Time frame: Week 16

    Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

  3. Global Psychopathology Score as Measured by Clinical Global Impressions

    Time frame: Week 16

    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.

  4. Social and Occupational Functioning Scale

    Time frame: Week 16

    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.

  5. Montgomery Asberg Depression Rating Scale

    Time frame: Week 16

    Scale Range: 0-60. Lower scores indicate better outcomes.

  6. Young Mania Rating Scale

    Time frame: Week 16

    Scale Range: 0-60. Lower scores indicate better outcomes.

  7. Body Weight

    Time frame: Week 16

  8. Quality of Life Score as Measured by 12-item Short Form Health Survey

    Time frame: Week 16

    Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: Zip Ad

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2011
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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