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Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia
Plain-language guide to NCT01712646: phase 1, phase 2 randomized trial of Oxytocin, 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01712646
- Phase
- phase 1, phase 2
- Status
- terminated early
- Start
- 2012-10-05
- Completion (planned or actual)
- 2016-06-20
- Participants
- 18 (actual)
- Design
- randomized, treatment
- Conditions studied
- Childhood Onset Psychotic Disorders; Schizophrenia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested Oxytocin.
Background: \- Oxytocin is a chemical that the brain normally produces.
It plays an important part in the way humans and other animals act in social and emotional situations.
The registry classes the interventions as drug.
More on the Plan
Study Population: 72 patients (36 per group) with COS, ages 10 and above will be recruited.
All patients will be on stable medications for at least one month prior to this study.
Design: Two-week double-blind, placebo-controlled, parallel design trial of daily intranasal oxytocin.
Subsequent to the study period, a two-week extension of open label study medication will be offered to all participants, regardless of study group assignment.
Who Took Part
18 actual participants took part.
It was open to people of any sex aged from 10 years up to 99 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized and parallel-group study.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
It started in 2012-10-05 with completion listed for 2016-06-20.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Blood plasma oxytoxin levels. Neuocircuitry alterations in amygdale/cingulated. Brain activity alterations during exposure to social stimuli.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 18 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
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.