Schizophrenia
Conditions
Keywords
Schizophrenia, Appetite, Oxytocin
Brief summary
The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.
Interventions
DRUGOxytocin
Single dose intranasal oxytocin (24 IU)
DRUGPlacebo
Placebo- Sugar pill
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
All participants will receive both active drug and placebo, differences between treatment conditions will be analyzed due to small sample order effects will not be analyzed
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV diagnosis of schizophrenia or schizoaffective disorder * Male or Female * Age: 18 to 54 years * Caucasian or Non-Caucasian * Body Mass Index of ≥ 27 kg/m2 * One month of stable antipsychotic treatment (same medication regimen and same dose)
Exclusion criteria
* History of organic brain disease * DSM-IV diagnosis of Mental Retardation * DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) * DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) * Are pregnant or lactating * Meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.) * Are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical). * Have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC). * Have a medical illness, dietary restrictions, or food allergies that, in the view of the investigators, would compromise participation. * Are taking prostaglandins such as dinoprostone or misoprostol (because they interact with oxytocin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Consumption After Intervention | 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. |
Countries
United States
Participant flow
Pre-assignment details
17 participants were randomized, 16 participants participated in the trial. All data is available for only 16 participants
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin vs Placebo 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Oxytocin vs Placebo |
|---|---|
| Age, Continuous | 32 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 2 / 16 | 4 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Food Consumption After Intervention
We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the Test Meal consumed 90 minutes after the preload.
Time frame: 90 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin/Placebo | Food Consumption After Intervention | Oxytocin | 7.9 Grams | Standard Deviation 13 |
| Oxytocin/Placebo | Food Consumption After Intervention | Placebo | 7.4 Grams | Standard Deviation 12.4 |