Trial Outcomes & Findings for Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad) (NCT NCT01293825)

Results Overview

Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Week 16

Results posted on

2014-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication Adherence Bipolar Disorder n=30 Participants 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.
Age, Continuous	44.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) Past week	16.11 Percentage of doses Standard Deviation 16.46
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ) Past month	13.88 Percentage of doses Standard Deviation 14.08

SECONDARY outcome

Timeframe: Week 16

Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Treatment Adherence Score as Measured by the Morisky Rating Scale	2.90 units on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Week 16

Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Attitude Toward Medication Score as Measured by the Drug Attitude Inventory	6.10 units on a scale Standard Deviation 3.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Global Psychopathology Score as Measured by Clinical Global Impressions	2.25 units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Social and Occupational Functioning Scale	54.40 units on a scale Standard Deviation 9.46

SECONDARY outcome

Timeframe: Week 16

Scale Range: 0-60. Lower scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Montgomery Asberg Depression Rating Scale	12.35 units on a scale Standard Deviation 11.21

SECONDARY outcome

Timeframe: Week 16

Scale Range: 0-60. Lower scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Young Mania Rating Scale	5.30 units on a scale Standard Deviation 5.82

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
Body Weight	210.75 lbs Standard Deviation 60.94

SECONDARY outcome

Timeframe: Week 16

Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Medication Adherence Bipolar Disorder n=20 Participants 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.
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
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

Adverse Events

Medication Adherence Bipolar Disorder

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medication Adherence Bipolar Disorder n=30 participants at risk 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.
Skin and subcutaneous tissue disorders Rashes	3.3% 1/30 • Number of events 1
Psychiatric disorders Psychiatric Hospitalization	16.7% 5/30 • Number of events 5
Metabolism and nutrition disorders High Blood Glucose	3.3% 1/30 • Number of events 2
General disorders Swollen Tongue and Facial Distortion	3.3% 1/30 • Number of events 1
General disorders Car Accident	3.3% 1/30 • Number of events 1
General disorders Fall	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sinus Infection	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchitis	3.3% 1/30 • Number of events 1
Hepatobiliary disorders Gallstones	3.3% 1/30 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Martha Sajatovic, Professor of Psychiatry

University Hospitals of Cleveland

Phone: (216) 844-2808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place