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Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Plain-language guide to NCT01614093: phase 4 randomized trial of Oxytocin, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01614093
- Phase
- phase 4
- Status
- completed
- Start
- 2012-06
- Completion (planned or actual)
- 2014-01
- Participants
- 24 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Schizophrenia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Oxytocin.
It had two arms (groups): Oxytocin/Placebo (active comparator) and Placebo/Oxytocin (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 54 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: 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).
How the Study Was Run
It was run as a randomized, crossover and quadruple-blind study.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2012-06 with completion listed for 2014-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Food Consumption After Intervention (time frame: 90 minutes).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 24 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.