Trial · NCT01866098

Naltrexone for Antipsychotic-Induced Weight Gain

NCT01866098, Not applicable, Completed, Yale University; results first posted 2020-04-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Naltrexone for Antipsychotic-Induced Weight Gain. Trials, record NCT01866098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01866098

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Naltrexone for Antipsychotic-Induced Weight Gain
NCT number: NCT01866098
Status: Completed
Phases: Not applicable
Enrollment: 144 participants, actual
Lead sponsor: Yale University
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Severe Major Depression With Psychotic Features
Interventions: Naltrexone, Placebo
First posted: 2013-05-31
Last updated: 2021-10-01
Results first posted: 2020-04-08

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Weight From Baseline	Baseline and 52 weeks	Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.
Primary	Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	52 weeks	Body Mass Index will be calculated at each assessment and change over time will be assessed at endpoint.
Secondary	Changes in Fasting Glucose From Baseline	Baseline and 52 weeks	Fasting glucose will be collected over the course of participation and changes will be evaluated at study endpoint.
Secondary	Changes in Glycosylated Hemoglobin (HbA1c) From Baseline	Baseline and 52 weeks	Glycosylated hemoglobin (HbA1c) will be collected over the course of participation and changes will be evaluated at study endpoint.
Secondary	Changes in Insulin From Baseline	Baseline and 52 weeks	Insulin will be collected over the course of participation and changes will be evaluated at study endpoint.
Secondary	Changes in Total Cholesterol From Baseline	Baseline and 52 weeks	Total Cholesterol will be collected over the course of participation and changes will be evaluated at study endpoint.
Secondary	Changes in HDL From Baseline	Baseline and 52 weeks	High-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.
Secondary	Changes in LDL From Baseline	Baseline and 52 weeks	Low-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Weight From Baseline	Baseline and 52 weeks	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.	kg	LEAST_SQUARES_MEAN
PRIMARY	Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	52 weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Fasting Glucose From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Changes in Glycosylated Hemoglobin (HbA1c) From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Changes in Insulin From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Changes in Total Cholesterol From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Changes in HDL From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Changes in LDL From Baseline	Baseline and 52 weeks	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.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Weight From Baseline	Placebo	-0.16	Standard Error 1.78	kg
Change in Weight From Baseline	Naltrexone 25mg	0.69	Standard Error 2.22	kg
Change in Weight From Baseline	Naltrexone 50mg	-0.95	Standard Error 2.06	kg
Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	Placebo	10		Participants
Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	Naltrexone 25mg	4		Participants
Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	Naltrexone 50mg	9		Participants
Changes in Fasting Glucose From Baseline	Placebo	8.2	Standard Error 2.6	mg/dL
Changes in Fasting Glucose From Baseline	Naltrexone 25mg	4.6	Standard Error 3.2	mg/dL
Changes in Fasting Glucose From Baseline	Naltrexone 50mg	-0.4	Standard Error 2.9	mg/dL
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline	Placebo	-0.007	Standard Error 0.11	mg/dL

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	51
Overall Study	STARTED	Naltrexone 25mg	47
Overall Study	STARTED	Naltrexone 50mg	46
Overall Study	COMPLETED	Placebo	32
Overall Study	COMPLETED	Naltrexone 25mg	20
Overall Study	COMPLETED	Naltrexone 50mg	25
Overall Study	NOT COMPLETED	Placebo	19
Overall Study	NOT COMPLETED	Naltrexone 25mg	27
Overall Study	NOT COMPLETED	Naltrexone 50mg	21

Source ClinicalTrials.gov

Adverse events51

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Concentration difficulties	Nervous system disorders	Placebo	0	51
other	Concentration difficulties	Nervous system disorders	Naltrexone 25mg	0	47
other	Concentration difficulties	Nervous system disorders	Naltrexone 50mg	3	46
other	Asthenia/Fatigability	General disorders	Placebo	2	51
other	Asthenia/Fatigability	General disorders	Naltrexone 25mg	2	47
other	Asthenia/Fatigability	General disorders	Naltrexone 50mg	5	46
other	Sleepiness/Sedation	Nervous system disorders	Placebo	3	51
other	Sleepiness/Sedation	Nervous system disorders	Naltrexone 25mg	5	47
other	Sleepiness/Sedation	Nervous system disorders	Naltrexone 50mg	2	46
other	Depression	Psychiatric disorders	Placebo	3	51

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	51
Total, all-cause mortality	Naltrexone 25mg	1	47
Total, all-cause mortality	Naltrexone 50mg	0	46
Total, other adverse events	Placebo	35	51
Total, other adverse events	Naltrexone 25mg	33	47
Total, other adverse events	Naltrexone 50mg	35	46
Total, serious adverse events	Placebo	0	51
Total, serious adverse events	Naltrexone 25mg	1	47
Total, serious adverse events	Naltrexone 50mg	0	46

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23805859	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK093924	NALTREXONE FOR ANTIPSYCHOTIC-INDUCED WEIGHT GAIN	TEK, CENK	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2013 to 2017

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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