Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
Condition: Medication Adherence; Bipolar Disorder
MeSH terms: Weight Gain; Bipolar Disorder
Intervention: ziprasidone
Intervention description: 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 MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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