Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT00538642
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder	Drug: ziprasidone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Stay on current antipsychotic Subjects stay on same daily oral antipsychotic treatment as at baseline. Dose adjustments allowable as clinically indicated.
Active Comparator: ziprasidone treatment Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level.	Drug: ziprasidone; Patients assigned to ziprasidone arm are cross-titrated from current antipsychotic; Other Names: Geodon

Outcome Measures

Primary Outcome Measures

1. Insulin Sensitivity [Baseline]

   Euglycemic clamp method

2. Insulin Sensitivity [4-5 months]

   Euglycemic clamp method

Secondary Outcome Measures

1. Body Mass Index [Baseline]

2. Body Mass Index [4-5 months]

3. Abdominal Circumference [Baseline]

4. Abdominal Circumference [4-5 months]

5. Systolic Blood Pressure [Baseline]

6. Systolic Blood Pressure [4-5 months]

7. Diastolic Blood Pressure [Baseline]

8. Diastolic Blood Pressure [4-5 months]

9. Triglycerides [Baseline]

10. Triglycerides [4-5 months]

11. Cholesterol [Baseline]

12. Cholesterol [4-5 months]

13. HDL Cholesterol [Baseline]

14. HDL Cholesterol [4-5 months]

15. LDL Cholesterol [Baseline]

16. LDL Cholesterol [4-5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder

• BMI>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men

• Pre-diabetic oral glucose tolerance test

• Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these

• Willing to switch to ziprasidone

• No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch

• Able to give informed consent to study

Exclusion Criteria:

• Judged to be currently suicidal, homicidal, or unable to cooperate with treatment

• Unstable serious medical illness

• Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). The use of "statins" and fibrates will be allowed ONLY if stable dose for past 3 months.

• Current diagnosis of diabetes

• Fasting blood glucose >125 mg/dl

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center At San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: ALEXANDER L MILLER, MD, The University of Texas Health Science Center at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander L. Miller, Principal Investigator, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT00538642
• Other Study ID Numbers: 000000010002968; 124932
• First Posted: Oct 3, 2007
• Last Update Posted: Nov 29, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Alexander L. Miller, Principal Investigator, The University of Texas Health Science Center at San Antonio: schizophrenia; antipsychotics; diabetes; bipolar disorder
• Additional relevant MeSH terms: Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Ziprasidone

Study Results

Participant Flow

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Period Title: Overall Study
STARTED	10	14
COMPLETED	9	9
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment	Total
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)	Total of all reporting groups
Overall Participants	10	14	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	14 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.6 (9.05)	41.43 (8.46)	40.25 (8.63)
Sex: Female, Male (Count of Participants)
Female	6 60%	8 57.1%	14 58.3%
Male	4 40%	6 42.9%	10 41.7%
Region of Enrollment (participants) [Number]
United States	10 100%	14 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Insulin Sensitivity
Description	Euglycemic clamp method
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg glucose/kg.min/μIU insulin]	5.55 (3.51)	1.88 (1.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stay on Current Antipsychotic, Ziprasidone Treatment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Body Mass Index
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [Kg/m2]	38.4 (10.5)	39.0 (4.1)

3. Secondary Outcome

Title	Body Mass Index
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [Kg/m2]	36.0 (6.4)	38.8 (4.2)

4. Secondary Outcome

Title	Abdominal Circumference
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [cm]	115 (20)	126 (17)

5. Secondary Outcome

Title	Abdominal Circumference
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [cm]	115 (19)	122 (8)

6. Secondary Outcome

Title	Systolic Blood Pressure
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mm Hg]	118 (15)	121 (13)

7. Secondary Outcome

Title	Systolic Blood Pressure
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mm Hg]	123 (15)	128 (15)

8. Secondary Outcome

Title	Diastolic Blood Pressure
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mm Hg]	81 (10)	80 (9)

9. Secondary Outcome

Title	Diastolic Blood Pressure
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mm Hg]	82 (9)	81 (13)

10. Secondary Outcome

Title	Triglycerides
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	183 (166)	227 (154)

11. Secondary Outcome

Title	Triglycerides
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	154 (87)	252 (179)

12. Secondary Outcome

Title	Cholesterol
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	176 (53)	176 (36)

13. Secondary Outcome

Title	Cholesterol
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	177 (34)	186 (44)

14. Secondary Outcome

Title	HDL Cholesterol
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	34 (8)	35 (5)

15. Secondary Outcome

Title	HDL Cholesterol
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	40 (9)	38 (9)

16. Secondary Outcome

Title	LDL Cholesterol
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	108 (43)	106 (35)

17. Secondary Outcome

Title	LDL Cholesterol
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg/dL]	106 (29)	109 (35)

18. Primary Outcome

Title	Insulin Sensitivity
Description	Euglycemic clamp method
Time Frame	4-5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stay on Current Antipsychotic	Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.	Subjects switch to ziprasidone from current antipsychotic(s)
Measure Participants	9	9
Mean (Standard Deviation) [mg glucose/kg.min/μIU insulin]	6.01 (3.93)	2.07 (1.15)

Adverse Events

Arm/Group Title	Stay on Current Antipsychotic		Ziprasidone Treatment
Arm/Group Description	Subjects stay on same antipsychotic treatment as at baseline.		Subjects switch to ziprasidone from current antipsychotic(s)
All Cause Mortality
	Stay on Current Antipsychotic		Ziprasidone Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stay on Current Antipsychotic		Ziprasidone Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Stay on Current Antipsychotic		Ziprasidone Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.