Phase 4
Completed N=30
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)
Medication Adherence · Bipolar Disorder
Source: ClinicalTrials.gov NCT01293825 ↗
Enrolled (actual)
30
Serious AEs
40.0%
Results posted
Apr 2014
Primary outcomePrimary: Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) — 16.11; 13.88 Percentage of doses
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) |
16.11; 13.88 | — |
| SECONDARY Treatment Adherence Score as Measured by the Morisky Rating Scale |
2.90 | — |
| SECONDARY Attitude Toward Medication Score as Measured by the Drug Attitude Inventory |
6.10 | — |
| SECONDARY Global Psychopathology Score as Measured by Clinical Global Impressions |
2.25 | — |
| SECONDARY Social and Occupational Functioning Scale |
54.40 | — |
| SECONDARY Montgomery Asberg Depression Rating Scale |
12.35 | — |
| SECONDARY Young Mania Rating Scale |
5.30 | — |
| SECONDARY Body Weight |
210.75 | — |
| SECONDARY Quality of Life Score as Measured by 12-item Short Form Health Survey |
41.13; 42.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01293825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.