Trial Outcomes & Findings for Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia (NCT NCT01614093)

NCT ID: NCT01614093

Last Updated: 2019-08-28

Results Overview

We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 90 minutes
• Results posted on: 2019-08-28

Participant Flow

17 participants were randomized, 16 participants participated in the trial. All data is available for only 16 participants

Participant milestones

Measure	Oxytocin/ Placebo Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Oxytocin/ Placebo Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Baseline characteristics by cohort

Measure	Oxytocin vs Placebo n=16 Participants Participants rated themselves as significantly less hungry when administered OT (M=36.37, SD=21.0) than placebo (M=44.81, SD=28.6) at 60 min. post-preload, F(5, 15)=8.05, p=0.012.
Age, Continuous	32 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: 90 minutes

We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.

Outcome measures

Measure	Oxytocin/Placebo n=16 Participants Each participant received intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
Food Consumption After Intervention Oxytocin	7.9 Grams Standard Deviation 13.0
Food Consumption After Intervention Placebo	7.4 Grams Standard Deviation 12.4

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxytocin n=16 participants at risk Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.	Placebo n=16 participants at risk Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
General disorders Loss of Appetite	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Bruisng Easily	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
Gastrointestinal disorders Constipation	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Dizziness	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Enuresis	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Malise	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Hyersalavation	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
General disorders Sedation	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	12.5% 2/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)
Musculoskeletal and connective tissue disorders Stiffness	0.00% 0/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)	6.2% 1/16 • Adverse events were collected over a period of about 4 weeks (on each of the visit days)

Additional Information

Kimberly R. Warren, Ph.D.

Morgan State University

Phone: 443-885-3492

Email: kimberly.warren@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place