Clinical trial NCT01293825: Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
Official title: Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medication Adherence
Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
timeFrame: Week 16
Secondary outcomes:
measure: Treatment Adherence Score as Measured by the Morisky Rating Scale
timeFrame: Week 16
measure: Attitude Toward Medication Score as Measured by the Drug Attitude Inventory
timeFrame: Week 16
measure: Global Psychopathology Score as Measured by Clinical Global Impressions
timeFrame: Week 16
measure: Social and Occupational Functioning Scale
timeFrame: Week 16
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Week 16
measure: Young Mania Rating Scale
timeFrame: Week 16
measure: Body Weight
timeFrame: Week 16
measure: Quality of Life Score as Measured by 12-item Short Form Health Survey
timeFrame: Week 16
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References: