Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication Adherence Bipolar Disorder | Experimental | There was only one group in this study. All participants received the study drug Ziprasidone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Attitude Toward Medication Score as Measured by the Drug Attitude Inventory |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, M.D. | Case Western Reserve University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes. |
| Week 16 |
| 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. | Week 16 |
| 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. | Week 16 |
| Montgomery Asberg Depression Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Week 16 |
| Young Mania Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Week 16 |
| Body Weight | Week 16 |
| Quality of Life Score as Measured by 12-item Short Form Health Survey | Scale Range: 1-99th percentile score. Higher scores indicate better outcomes. | Week 16 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percentage of doses | Week 16 |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Montgomery Asberg Depression Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Young Mania Rating Scale | Scale Range: 0-60. Lower scores indicate better outcomes. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Body Weight | Posted | Mean | Standard Deviation | lbs | Week 16 |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 12 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rashes | Skin and subcutaneous tissue disorders |
| |||
| Psychiatric Hospitalization | Psychiatric disorders |
| |||
| High Blood Glucose | Metabolism and nutrition disorders |
| |||
| Swollen Tongue and Facial Distortion | General disorders |
| |||
| Car Accident | General disorders | Participant passed out while driving. The accident may have been related to new-onset elevated blood pressure. |
| ||
| Fall | General disorders | Participant fell down stairs while carrying dishes. Hospitalized with internal bleeding and a ruptured spleen. |
| ||
| Sinus Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Bronchitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Gallstones | Hepatobiliary disorders | Participant reported having had recurrent abdominal pain for many years. Sought treatment in December 2011 and was found to have gallstones. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Sajatovic, Professor of Psychiatry | University Hospitals of Cleveland | (216) 844-2808 | martha.sajatovic@uhhospitals.org |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C092292 | ziprasidone |
Not provided
Not provided
Not provided
| >=65 years |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Norm-Based Standardized PCS Score |
| |||||
| Norm-Based Standardized MCS Score |
|