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Pharmacological Approach to Improve the Outcome of Social Cognition Training
Plain-language guide to NCT01517360: phase 1 randomized trial of Oxytocin, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01517360
- Phase
- phase 1
- Status
- completed
- Start
- 2012-01
- Completion (planned or actual)
- 2013-02
- Participants
- 27 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Schizophrenia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Oxytocin.
It had two arms (groups): Placebo+Social Cognitive Skills Training (active comparator) and Oxytocin+Social Cognitive Skill Training (experimental).
The registry classes the interventions as behavioral, drug and other.
More on the Plan
These deficits in social cognition can lead to misunderstanding the intentions of others and failing to interpret social signals that are important for successful social interactions.
Who Took Part
Enrollment: 27 actual participants took part.
It was open to men only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Stable on an antipsychotic medication.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: unable to provide informed consent; history of epilepsy; history of serious head injury.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
The Oxytocin group and the comparison group ran side by side rather than switching.
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 2012-01 with completion listed for 2013-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Composite Social Cognition Score (time frame: Baseline, 6 weeks, and 10 weeks).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 27 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.