Trial Outcomes & Findings for Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia (NCT NCT00793780)
NCT ID: NCT00793780
Last Updated: 2016-10-06
Results Overview
Weight was measured with shoes off to the nearest 0.1 kg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-10-06
Participant Flow
Participant milestones
| Measure |
Naltrexone 25mg
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
Randomization
|
12
|
12
|
|
Overall Study
Collected Baseline Data
|
11
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Naltrexone 25mg
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Baseline characteristics by cohort
| Measure |
Naltrexone 25mg
n=11 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=12 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
46.93 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnosis
Schizophrenia
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Diagnosis
Schizoaffective
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
PANSS Total Score
|
64.7 units on a scale
STANDARD_DEVIATION 17.2 • n=5 Participants
|
56.0 units on a scale
STANDARD_DEVIATION 16.7 • n=7 Participants
|
59.78 units on a scale
STANDARD_DEVIATION 16.42 • n=5 Participants
|
|
Diabetes
Diabetic
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Diabetes
Non-Diabetic
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Years of education
|
13.4 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
13.7 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
13.52 years
STANDARD_DEVIATION 3.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksWeight was measured with shoes off to the nearest 0.1 kg.
Outcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Change in Body Weight From Baseline
|
-3.40 kg
Interval -5.16 to -1.65
|
1.37 kg
Interval -0.3 to 3.03
|
SECONDARY outcome
Timeframe: baseline and 8 weeksOutcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Fasting Serum Glucose Lab Values
baseline
|
113.40 mg/dL
Standard Deviation 28.2
|
93.82 mg/dL
Standard Deviation 7.9
|
|
Fasting Serum Glucose Lab Values
Week 8
|
129.22 mg/dL
Standard Deviation 45.2
|
94.11 mg/dL
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 8 weeksThe PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.
Outcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
PANSS- Positive and Negative Symptom Scale
|
57.50 units on a scale
Standard Deviation 16.17
|
52.63 units on a scale
Standard Deviation 17.91
|
SECONDARY outcome
Timeframe: baseline and week 8Determined with a double-antibody radioimmunoassay
Outcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Insulin Levels
baseline
|
26.42 microIU/mL
Standard Deviation 40.0
|
13.84 microIU/mL
Standard Deviation 10.8
|
|
Insulin Levels
Week 8
|
35.51 microIU/mL
Standard Deviation 42.0
|
12.36 microIU/mL
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: baseline and week 8Determined by standard enzymatic procedures
Outcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
LDL Cholesterol
baseline
|
86.80 mg/dL
Standard Deviation 26.2
|
123.18 mg/dL
Standard Deviation 41.3
|
|
LDL Cholesterol
Week 8
|
104.11 mg/dL
Standard Deviation 39.9
|
111.22 mg/dL
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: baseline and week 8The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.
Outcome measures
| Measure |
Naltrexone 25mg
n=10 Participants
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Change in Questionnaire on Craving for Sweet or Rich Foods Score
|
-3.10 units on a scale
Standard Deviation 3.92
|
0 units on a scale
Standard Deviation 4.31
|
Adverse Events
Naltrexone 25mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone 25mg
n=10 participants at risk
Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
|
Placebo
n=11 participants at risk
Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
|
|---|---|---|
|
Psychiatric disorders
Concentration
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
9.1%
1/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Fatigue
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Sedation
|
40.0%
4/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Psychiatric disorders
Failing Memory
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Tension
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
18.2%
2/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Increased Sleep
|
30.0%
3/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Decreased Sleep
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Increased Dreaming
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
18.2%
2/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Psychiatric disorders
Emotional Indifference
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Musculoskeletal and connective tissue disorders
Dystonia
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Musculoskeletal and connective tissue disorders
Rigidity
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Headache
|
0.00%
0/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
9.1%
1/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Increased Saliva
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Dry Mouth
|
20.0%
2/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
18.2%
2/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
9.1%
1/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Dizziness
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Photosensitivity
|
20.0%
2/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Weight Loss
|
30.0%
3/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
9.1%
1/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
|
General disorders
Decreased Sexual Desire
|
10.0%
1/10 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
0.00%
0/11 • Adverse events were collected at the start of medication, week 2, week 4, week 6 and week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place