Trial Outcomes & Findings for Glucose and Lipid Metabolism on Antipsychotic Medication (NCT NCT00515723)
NCT ID: NCT00515723
Last Updated: 2019-10-02
Results Overview
This study hypothesized that antipsychotic treatment would increase total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
The relevant time points include baseline, week 6 and week 12.
Results posted on
2019-10-02
Participant Flow
Participants were recruited from wide range of sites in the St. Louis community. Some advertising with flyers was used however the majority of the recruitment was done using community outreach,doctor-to-doctor or self-referrals, and referrals from board and care and community support programs. All recruitment materials were approved by the IRB.
Participants were enrolled in the study once they signed consent. After enrollment, participants were brought in for a screening visit consisting of a diagnostic interview, screening labs, a review of records and a discussion with their primary psychiatrist. If the patient met all inclusion criteria after screening, study visits were scheduled.
Participant milestones
| Measure |
Olanzapine
Participants in this group were randomized to flexibly-dosed treatment with olanzapine.
|
Risperidone
Participants in this group were randomized to flexibly-dosed treatment with risperidone.
|
Quetiapine
Participants in this group were randomized to flexibly-dosed treatment with quetiapine.
|
Ziprasidone
Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
22
|
27
|
|
Overall Study
COMPLETED
|
20
|
21
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 participants were missing a baseline DEXA scan.
Baseline characteristics by cohort
| Measure |
Olanzapine
n=25 Participants
Participants with schizophrenia were randomized to olanzapine.
|
Risperidone
n=22 Participants
Patients with schizophrenia were randomized to risperidone.
|
Quetiapine
n=22 Participants
Participants with schizophrenia were randomized to quetiapine.
|
Ziprasidone
n=27 Participants
Participants with schizophrenia were randomized to ziprasidone.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.2 • n=25 Participants
|
39.2 years
STANDARD_DEVIATION 11.1 • n=22 Participants
|
36.4 years
STANDARD_DEVIATION 8.6 • n=22 Participants
|
38.3 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
37.9 years
STANDARD_DEVIATION 10.2 • n=96 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=25 Participants
|
4 Participants
n=22 Participants
|
9 Participants
n=22 Participants
|
11 Participants
n=27 Participants
|
31 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
18 Participants
n=22 Participants
|
13 Participants
n=22 Participants
|
16 Participants
n=27 Participants
|
65 Participants
n=96 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=25 Participants
|
7 Participants
n=22 Participants
|
4 Participants
n=22 Participants
|
11 Participants
n=27 Participants
|
30 Participants
n=96 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
17 Participants
n=25 Participants
|
15 Participants
n=22 Participants
|
17 Participants
n=22 Participants
|
16 Participants
n=27 Participants
|
65 Participants
n=96 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=25 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=96 Participants
|
|
Body Weight
|
98.75 kilograms
STANDARD_DEVIATION 21.04 • n=25 Participants
|
93.88 kilograms
STANDARD_DEVIATION 19.19 • n=22 Participants
|
92.95 kilograms
STANDARD_DEVIATION 18.67 • n=22 Participants
|
94.68 kilograms
STANDARD_DEVIATION 15.90 • n=27 Participants
|
95.16 kilograms
STANDARD_DEVIATION 18.56 • n=96 Participants
|
|
Body Mass Index
|
32.27 kilograms per squared meters
STANDARD_DEVIATION 7.38 • n=25 Participants
|
31.04 kilograms per squared meters
STANDARD_DEVIATION 6.50 • n=22 Participants
|
31.76 kilograms per squared meters
STANDARD_DEVIATION 6.63 • n=22 Participants
|
32.27 kilograms per squared meters
STANDARD_DEVIATION 5.56 • n=27 Participants
|
31.87 kilograms per squared meters
STANDARD_DEVIATION 6.45 • n=96 Participants
|
|
Waist Circumference
|
108.44 centimeters
STANDARD_DEVIATION 16.74 • n=25 Participants
|
102.87 centimeters
STANDARD_DEVIATION 16.66 • n=22 Participants
|
104.10 centimeters
STANDARD_DEVIATION 15.45 • n=22 Participants
|
108.50 centimeters
STANDARD_DEVIATION 15.18 • n=27 Participants
|
106.19 centimeters
STANDARD_DEVIATION 15.95 • n=96 Participants
|
|
DEXA Total Fat
|
32.24 kilograms
STANDARD_DEVIATION 13.49 • n=25 Participants • 3 participants were missing a baseline DEXA scan.
|
24.95 kilograms
STANDARD_DEVIATION 10.07 • n=20 Participants • 3 participants were missing a baseline DEXA scan.
|
28.69 kilograms
STANDARD_DEVIATION 11.63 • n=21 Participants • 3 participants were missing a baseline DEXA scan.
|
31.60 kilograms
STANDARD_DEVIATION 11.22 • n=27 Participants • 3 participants were missing a baseline DEXA scan.
|
29.68 kilograms
STANDARD_DEVIATION 11.89 • n=93 Participants • 3 participants were missing a baseline DEXA scan.
|
|
Whole Body Sensitivity
|
4.39 mg/kg/min
STANDARD_DEVIATION 2.16 • n=24 Participants • Two participants were missing data due to bad veins.
|
5.53 mg/kg/min
STANDARD_DEVIATION 3.32 • n=21 Participants • Two participants were missing data due to bad veins.
|
5.10 mg/kg/min
STANDARD_DEVIATION 2.93 • n=22 Participants • Two participants were missing data due to bad veins.
|
4.33 mg/kg/min
STANDARD_DEVIATION 2.01 • n=27 Participants • Two participants were missing data due to bad veins.
|
4.79 mg/kg/min
STANDARD_DEVIATION 2.62 • n=94 Participants • Two participants were missing data due to bad veins.
|
PRIMARY outcome
Timeframe: The relevant time points include baseline, week 6 and week 12.Population: Modified Intent to Treat (ITT) sample with week 0, week 6 and week 12 data. Two Quetiapine participants were excluded from analyses due to failure to adhere to the protocol.
This study hypothesized that antipsychotic treatment would increase total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine.
Outcome measures
| Measure |
Olanzapine
n=25 Participants
Participants in this group were randomized to flexibly-dosed treatment with olanzapine.
|
Risperidone
n=22 Participants
Participants in this group were randomized to flexibly-dosed treatment with risperidone.
|
Quetiapine
n=20 Participants
Participants in this group were randomized to flexibly-dosed treatment with quetiapine.
|
Ziprasidone
n=27 Participants
Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.
|
Total
n=94 Participants
This arm consists of all treatments pooled together.
|
|---|---|---|---|---|---|
|
DEXA Total Fat
Baseline
|
32.24 kilograms of body fat
Standard Error 2.48
|
27.66 kilograms of body fat
Standard Error 2.64
|
28.83 kilograms of body fat
Standard Error 2.77
|
31.60 kilograms of body fat
Standard Error 2.38
|
30.25 kilograms of body fat
Standard Error 1.27
|
|
DEXA Total Fat
6 Weeks
|
34.38 kilograms of body fat
Standard Error 2.48
|
28.29 kilograms of body fat
Standard Error 2.64
|
29.60 kilograms of body fat
Standard Error 2.77
|
31.18 kilograms of body fat
Standard Error 2.39
|
31.05 kilograms of body fat
Standard Error 1.27
|
|
DEXA Total Fat
12 Weeks
|
35.45 kilograms of body fat
Standard Error 2.49
|
29.23 kilograms of body fat
Standard Error 2.64
|
30.10 kilograms of body fat
Standard Error 2.77
|
30.66 kilograms of body fat
Standard Error 2.40
|
31.52 kilograms of body fat
Standard Error 1.28
|
PRIMARY outcome
Timeframe: The relevant time points include baseline and week 12.Population: Modified Intent to Treat (ITT) sample with Week 0 and Week 12 data. Two Quetiapine participants were excluded from analyses due to failure to adhere to the protocol.
This study hypothesized that antipsychotic treatment would decrease insulin sensitivity, with larger adverse effects for olanzapine. Insulin sensitivity describes how sensitive the body is to the effects of insulin.
Outcome measures
| Measure |
Olanzapine
n=25 Participants
Participants in this group were randomized to flexibly-dosed treatment with olanzapine.
|
Risperidone
n=22 Participants
Participants in this group were randomized to flexibly-dosed treatment with risperidone.
|
Quetiapine
n=20 Participants
Participants in this group were randomized to flexibly-dosed treatment with quetiapine.
|
Ziprasidone
n=27 Participants
Participants in this group were randomized to flexibly-dosed treatment with ziprasidone.
|
Total
n=94 Participants
This arm consists of all treatments pooled together.
|
|---|---|---|---|---|---|
|
Clamp Derived Insulin Sensitivity (mg/kg/Min)
Baseline
|
4.39 mg/kg/min
Standard Error 0.53
|
5.53 mg/kg/min
Standard Error 0.57
|
5.28 mg/kg/min
Standard Error 0.58
|
4.33 mg/kg/min
Standard Error 0.50
|
4.82 mg/kg/min
Standard Error 0.27
|
|
Clamp Derived Insulin Sensitivity (mg/kg/Min)
Week 12
|
3.62 mg/kg/min
Standard Error 0.49
|
5.01 mg/kg/min
Standard Error 0.51
|
5.08 mg/kg/min
Standard Error 0.53
|
4.45 mg/kg/min
Standard Error 0.47
|
4.50 mg/kg/min
Standard Error 0.25
|
Adverse Events
Olanzapine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Risperidone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ziprasidone
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine
n=19 participants at risk
Participants with schizophrenia were randomized to olanzapine.
|
Risperidone
n=21 participants at risk
Patients with schizophrenia were randomized to risperidone.
|
Quetiapine
n=20 participants at risk
Participants with schizophrenia were randomized to quetiapine.
|
Ziprasidone
n=21 participants at risk
Participants with schizophrenia were randomized to ziprasidone.
|
|---|---|---|---|---|
|
Psychiatric disorders
Drowsiness/Somnolence
|
47.4%
9/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
14.3%
3/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
25.0%
5/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
28.6%
6/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Tiredness/Fatigue
|
42.1%
8/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
19.0%
4/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
20.0%
4/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
19.0%
4/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Hunger
|
26.3%
5/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
14.3%
3/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
15.0%
3/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
9.5%
2/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
9.5%
2/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
10.0%
2/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
9.5%
2/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Restlessness
|
5.3%
1/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
4.8%
1/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
5.0%
1/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
14.3%
3/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Headache
|
5.3%
1/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
4.8%
1/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
15.0%
3/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
0.00%
0/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Difficulty Concentrating
|
0.00%
0/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
0.00%
0/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
0.00%
0/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
14.3%
3/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
|
Psychiatric disorders
Tremor
|
0.00%
0/19 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
0.00%
0/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
0.00%
0/20 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
14.3%
3/21 • Adverse events were collected during the study's primary time points, baseline and week 12. However, only adverse events at week 12 are provided as these are potentially related to the treatments. As a result, the sample sizes differ from the sample sizes found in the Participant Flow section as not everyone made it to week 12.
|
Additional Information
John Newcomer, M.D.
Washington University School of Medicine and Florida Atlantic University
Phone: 561-297-0252
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place