Bipolar Disorder, Medication Adherence
Conditions
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.
Interventions
DRUGziprasidone
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.
Sponsors
Pfizer
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence Score as Measured by the Morisky Rating Scale | Week 16 | 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 | Week 16 | 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 | 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. |
| Quality of Life Score as Measured by 12-item Short Form Health Survey | Week 16 | Scale Range: 1-99th percentile score. Higher scores indicate better outcomes. |
| Montgomery Asberg Depression Rating Scale | Week 16 | Scale Range: 0-60. Lower scores indicate better outcomes. |
| Young Mania Rating Scale | Week 16 | Scale Range: 0-60. Lower scores indicate better outcomes. |
| Body Weight | Week 16 | — |
| Social and Occupational Functioning Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medication Adherence Bipolar Disorder Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.
There was only one group for this study. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Medication Adherence Bipolar Disorder |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 44.2 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 12 / 30 |
Outcome results
Primary
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
Time frame: Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Adherence Bipolar Disorder | Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) | Past month | 13.88 Percentage of doses | Standard Deviation 14.08 |
| Medication Adherence Bipolar Disorder | Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) | Past week | 16.11 Percentage of doses | Standard Deviation 16.46 |
Secondary
Attitude Toward Medication Score as Measured by the Drug Attitude Inventory
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Attitude Toward Medication Score as Measured by the Drug Attitude Inventory | 6.10 units on a scale | Standard Deviation 3.08 |
Secondary
Body Weight
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Body Weight | 210.75 lbs | Standard Deviation 60.94 |
Secondary
Global Psychopathology Score as Measured by Clinical Global Impressions
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.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Global Psychopathology Score as Measured by Clinical Global Impressions | 2.25 units on a scale | Standard Deviation 1.29 |
Secondary
Montgomery Asberg Depression Rating Scale
Scale Range: 0-60. Lower scores indicate better outcomes.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Montgomery Asberg Depression Rating Scale | 12.35 units on a scale | Standard Deviation 11.21 |
Secondary
Quality of Life Score as Measured by 12-item Short Form Health Survey
Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.
Time frame: Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Adherence Bipolar Disorder | Quality of Life Score as Measured by 12-item Short Form Health Survey | Norm-Based Standardized PCS Score | 41.13 units on a scale | Standard Deviation 12.71 |
| Medication Adherence Bipolar Disorder | Quality of Life Score as Measured by 12-item Short Form Health Survey | Norm-Based Standardized MCS Score | 42.00 units on a scale | Standard Deviation 13.44 |
Secondary
Social and Occupational Functioning Scale
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.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Social and Occupational Functioning Scale | 54.40 units on a scale | Standard Deviation 9.46 |
Secondary
Treatment Adherence Score as Measured by the Morisky Rating Scale
Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Treatment Adherence Score as Measured by the Morisky Rating Scale | 2.90 units on a scale | Standard Deviation 1.25 |
Secondary
Young Mania Rating Scale
Scale Range: 0-60. Lower scores indicate better outcomes.
Time frame: Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Young Mania Rating Scale | 5.30 units on a scale | Standard Deviation 5.82 |