Trial Outcomes & Findings for Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia (NCT NCT00690235)
NCT ID: NCT00690235
Last Updated: 2018-11-16
Results Overview
Mean Number of Pounds Lost on Pramlintide Over 16 Weeks
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-11-16
Participant Flow
Participant milestones
| Measure |
Pramlintide
volunteers are given 180mg of pramlintide, twice daily
Pramlintide: 180mg subcutaneous injections, twice daily
|
Placebo
Patients will be given the Placebo for injection twice daily
Placebo: 180mg subcutaneous saline injections, twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
Baseline characteristics by cohort
| Measure |
Pramlintide
n=12 Participants
Volunteers are given 180mg of pramlintide, twice daily
Pramlintide: 180mg subcutaneous injections, twice daily
|
Placebo
n=12 Participants
Patients will be given the Placebo for injection twice daily
Placebo: 180mg subcutaneous injections, twice daily
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksMean Number of Pounds Lost on Pramlintide Over 16 Weeks
Outcome measures
| Measure |
Pramlintide
n=12 Participants
Volunteers are given 180mg of pramlintide, twice daily
Pramlintide: 180mg subcutaneous injections, twice daily
|
Placebo
n=12 Participants
Volunteers will be given the Placebo for injection twice daily
Placebo: 180mg subcutaneous injections, twice daily
|
|---|---|---|
|
Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
|
37 pounds
Standard Deviation 143.06
|
40.5 pounds
Standard Deviation 109.26
|
Adverse Events
Pramlintide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pramlintide
n=12 participants at risk
volunteers are given 180mg of pramlintide, twice daily
Pramlintide: 180mg subcutaneous injections, twice daily
|
Placebo
n=12 participants at risk
Patients will be given the Placebo for injection twice daily
Placebo: 180mg subcutaneous injections, twice daily
|
|---|---|---|
|
Psychiatric disorders
Pain/bruise at injection site
|
16.7%
2/12 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
Additional Information
Carol A. Tamminga, MD
University of Texas Southwestern Medical Center
Phone: 214-645-2789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place