Trial Outcomes & Findings for Naltrexone for Antipsychotic-Induced Weight Gain (NCT NCT01866098)
NCT ID: NCT01866098
Last Updated: 2021-10-01
Results Overview
Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
Baseline and 52 weeks
Results posted on
2021-10-01
Participant Flow
Participant milestones
| Measure |
Placebo
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
47
|
46
|
|
Overall Study
COMPLETED
|
32
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
19
|
27
|
21
|
Reasons for withdrawal
| Measure |
Placebo
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
18
|
13
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
5
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Unrelated Hospitalization
|
2
|
0
|
1
|
|
Overall Study
Non-compliance
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Naltrexone for Antipsychotic-Induced Weight Gain
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
46 participants
n=5 Participants
|
144 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
39.1 weight in kg/ height m^2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
37.1 weight in kg/ height m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
38.9 weight in kg/ height m^2
STANDARD_DEVIATION 11.4 • n=5 Participants
|
38.4 weight in kg/ height m^2
STANDARD_DEVIATION 8.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Change in Weight From Baseline
|
-0.16 kg
Standard Error 1.78
|
0.69 kg
Standard Error 2.22
|
-0.95 kg
Standard Error 2.06
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Body Mass Index will be calculated at each assessment and change over time will be assessed at endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline
|
10 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Fasting glucose will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in Fasting Glucose From Baseline
|
8.2 mg/dL
Standard Error 2.6
|
4.6 mg/dL
Standard Error 3.2
|
-0.4 mg/dL
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Glycosylated hemoglobin (HbA1c) will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline
|
-0.007 mg/dL
Standard Error 0.11
|
-0.061 mg/dL
Standard Error 0.15
|
0.060 mg/dL
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Insulin will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in Insulin From Baseline
|
6.45 mg/dL
Standard Error 4.89
|
0.45 mg/dL
Standard Error 6.23
|
2.16 mg/dL
Standard Error 5.55
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Total Cholesterol will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in Total Cholesterol From Baseline
|
-1.16 mg/dL
Standard Error 5.12
|
1.52 mg/dL
Standard Error 6.41
|
-3.02 mg/dL
Standard Error 5.72
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
High-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in HDL From Baseline
|
0.04 mg/dL
Standard Error 1.73
|
0.79 mg/dL
Standard Error 2.19
|
0.36 mg/dL
Standard Error 1.93
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.
Low-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 Participants
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 Participants
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Changes in LDL From Baseline
|
-10.87 mg/dL
Standard Error 4.47
|
1.14 mg/dL
Standard Error 5.46
|
-4.40 mg/dL
Standard Error 4.91
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Naltrexone 25mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 1 deaths
Naltrexone 50mg
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 participants at risk
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 participants at risk
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
General disorders
Cocaine Overdose
|
0.00%
0/51 • Up to 52 weeks.
|
2.1%
1/47 • Up to 52 weeks.
|
0.00%
0/46 • Up to 52 weeks.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Oral placebo capsule taken once daily for 52 weeks
Placebo
|
Naltrexone 25mg
n=47 participants at risk
Oral Naltrexone 25mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
Naltrexone 50mg
n=46 participants at risk
Oral Naltrexone 50mg capsule taken once daily for 52 weeks
Naltrexone: 25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
|
|---|---|---|---|
|
Nervous system disorders
Concentration difficulties
|
0.00%
0/51 • Up to 52 weeks.
|
0.00%
0/47 • Up to 52 weeks.
|
6.5%
3/46 • Up to 52 weeks.
|
|
General disorders
Asthenia/Fatigability
|
3.9%
2/51 • Up to 52 weeks.
|
4.3%
2/47 • Up to 52 weeks.
|
10.9%
5/46 • Up to 52 weeks.
|
|
Nervous system disorders
Sleepiness/Sedation
|
5.9%
3/51 • Up to 52 weeks.
|
10.6%
5/47 • Up to 52 weeks.
|
4.3%
2/46 • Up to 52 weeks.
|
|
Psychiatric disorders
Depression
|
5.9%
3/51 • Up to 52 weeks.
|
4.3%
2/47 • Up to 52 weeks.
|
0.00%
0/46 • Up to 52 weeks.
|
|
General disorders
Tension/Inner unrest
|
2.0%
1/51 • Up to 52 weeks.
|
6.4%
3/47 • Up to 52 weeks.
|
2.2%
1/46 • Up to 52 weeks.
|
|
Nervous system disorders
Increased sleep
|
5.9%
3/51 • Up to 52 weeks.
|
10.6%
5/47 • Up to 52 weeks.
|
2.2%
1/46 • Up to 52 weeks.
|
|
Nervous system disorders
Reduced sleep
|
13.7%
7/51 • Up to 52 weeks.
|
6.4%
3/47 • Up to 52 weeks.
|
21.7%
10/46 • Up to 52 weeks.
|
|
Nervous system disorders
Headache
|
29.4%
15/51 • Up to 52 weeks.
|
23.4%
11/47 • Up to 52 weeks.
|
28.3%
13/46 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Reduced salivation
|
11.8%
6/51 • Up to 52 weeks.
|
2.1%
1/47 • Up to 52 weeks.
|
2.2%
1/46 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Nausea
|
41.2%
21/51 • Up to 52 weeks.
|
42.6%
20/47 • Up to 52 weeks.
|
41.3%
19/46 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
21.6%
11/51 • Up to 52 weeks.
|
12.8%
6/47 • Up to 52 weeks.
|
15.2%
7/46 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Constipation
|
21.6%
11/51 • Up to 52 weeks.
|
21.3%
10/47 • Up to 52 weeks.
|
15.2%
7/46 • Up to 52 weeks.
|
|
Nervous system disorders
Dizziness
|
15.7%
8/51 • Up to 52 weeks.
|
17.0%
8/47 • Up to 52 weeks.
|
32.6%
15/46 • Up to 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
4/51 • Up to 52 weeks.
|
0.00%
0/47 • Up to 52 weeks.
|
2.2%
1/46 • Up to 52 weeks.
|
|
Psychiatric disorders
Diminished sexual desire
|
2.0%
1/51 • Up to 52 weeks.
|
4.3%
2/47 • Up to 52 weeks.
|
6.5%
3/46 • Up to 52 weeks.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/51 • Up to 52 weeks.
|
4.3%
2/47 • Up to 52 weeks.
|
15.2%
7/46 • Up to 52 weeks.
|
Additional Information
Associate Professor of Psychiatry; Director, Psychosis Program, CMHC
Connecticut Mental Health Center
Phone: (203) 974-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place