Trial Outcomes & Findings for Geodon in Weight Loss Study for Bipolar Disorders (NCT NCT00472641)

Last Updated: 2017-05-09

Results Overview

The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2017-05-09

Participant milestones
Measure	Ziprasidone/Geodon Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
Overall Study STARTED	25
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	Ziprasidone/Geodon Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1

Geodon in Weight Loss Study for Bipolar Disorders

Baseline characteristics by cohort
Measure	Ziprasidone/Geodon n=25 Participants Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
Age, Continuous	46.8 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants
Bipolar Subtype Bipolar 1	10 Participants n=5 Participants
Bipolar Subtype Bipolar 2	14 Participants n=5 Participants
Bipolar Subtype Bipolar NOS	1 Participants n=5 Participants
Weight	205.2 pounds STANDARD_DEVIATION 31.7 • n=5 Participants
BMI	32.9 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants
Waist Circumference	41.7 inches STANDARD_DEVIATION 4.4 • n=5 Participants

Timeframe: Baseline, 12 weeks

The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.

Outcome measures
Measure	Ziprasidone/Geodon n=25 Participants Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.	-9.8 Pounds Standard Deviation 7.5

Timeframe: Baseline, 12 weeks

Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).

Outcome measures
Measure	Ziprasidone/Geodon n=25 Participants Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
Changes From Baseline to Endpoint in Body Mass Index (BMI)	1.6 kg/m^2 Standard Deviation 1.2

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Ziprasidone/Geodon n=25 participants at risk Ziprasidone/Geodon up to 320 mg per day Ziprasidone/Geodon: Ziprasidone/Geodon
Gastrointestinal disorders Viral Gastroenteritis	4.0% 1/25 • Number of events 1 • 12 weeks
Vascular disorders Loss of Consciousness	4.0% 1/25 • Number of events 1 • 12 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	4.0% 1/25 • Number of events 1 • 12 weeks
Psychiatric disorders Hypomania	4.0% 1/25 • Number of events 1 • 12 weeks

Adverse event data not reported

Stanford University School of Medicine

Phone: 650-723-2483