One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated.

Reporting Groups

	Description
Ziprasidone	Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.

Participant Flow:   Overall Study

	Ziprasidone
STARTED	13
COMPLETED	0
NOT COMPLETED	13
Withdrawal by Subject	1
Protocol Violation	1
Study Terminated by Sponsor	7
Adverse Event	4

Reporting Groups

	Description
Ziprasidone	Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.

Baseline Measures

	Ziprasidone
Number of Participants   [units: participants]	13
Age   [units: years] Mean ± Standard Deviation	46.5  ± 10.7
Gender   [units: participants]
Female	9
Male	4

1.  Primary:

Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation   [ Time Frame: Week 52 or Early Termination ]

2.  Secondary:

Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)   [ Time Frame: Baseline, Week 52 ]

3.  Secondary:

Metabolic Syndrome (MS) Prevalence   [ Time Frame: Baseline through Week 52 ]

4.  Secondary:

Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor   [ Time Frame: Baseline through Week 52 ]

5.  Secondary:

Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors   [ Time Frame: Baseline through Week 52 ]

6.  Secondary:

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference   [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]

7.  Secondary:

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure   [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]

8.  Secondary:

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose   [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]

9.  Secondary:

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]

10.  Secondary:

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides   [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]

11.  Secondary:

Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System   [ Time Frame: Baseline, Week 4, Week 52 ]

12.  Secondary:

Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels   [ Time Frame: Baseline, Week 52 or Early Termination ]

13.  Secondary:

Change From Baseline in Weight   [ Time Frame: Baseline, Week 4, Week 12, Week 52 or Early Termination ]

14.  Secondary:

Change From Baseline in Body Mass Index (BMI)   [ Time Frame: Baseline, Week 4, Week 12, Week 52 or Early Termination ]

15.  Secondary:

Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, Week 52 or Early Termination ]

16.  Secondary:

Change From Baseline in Insulin Levels   [ Time Frame: Baseline, Week 52 or Early Termination ]

17.  Secondary:

Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)   [ Time Frame: Baseline, Week 4, Week 52 or Early Termination ]

18.  Secondary:

Change From Baseline in Apolipoprotein B (ApoB) Levels   [ Time Frame: Baseline, Week 52 or Early Termination ]

19.  Secondary:

Change From Baseline in Leptin   [ Time Frame: Baseline, Week 52 or Early Termination ]

20.  Secondary:

Change From Baseline in Physical Activity Index   [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]

21.  Secondary:

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score   [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]

22.  Secondary:

Change From Baseline in Young Mania Rating Scale (YMRS)   [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]

23.  Secondary:

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale   [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]

24.  Secondary:

Clinical Global Impression - Improvement (CGI-I) Subscale Score   [ Time Frame: Week 52 or Early Termination ]

25.  Secondary:

Change From Baseline in Drug Attitude Inventory (DAI)   [ Time Frame: Week 28, Week 52 or Early Termination ]

26.  Secondary:

Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)   [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]

27.  Secondary:

Change From Baseline in EuroQoL Index (EQ-I)   [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]

28.  Secondary:

Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score   [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]

29.  Secondary:

Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale   [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]

30.  Secondary:

Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])   [ Time Frame: Baseline, Week 1 through Week 52 or Early Termination ]