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Vasopressin Effects on Human Social Communication
Plain-language guide to NCT01327027: phase 1 randomized trial of Vasopressin, 225 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01327027
- Phase
- phase 1
- Status
- completed
- Start
- 2011-09
- Completion (planned or actual)
- 2015-12
- Participants
- 225 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Vasopressin.
This research is being done because the researchers wish to understand how a chemical produced in the brain, vasopressin, effects emotional social communication processes.
Understanding how this system works in normal individuals may help them understand why some people, particularly those with autism and/or antisocial personality disorder, have dysfunctional social interactions.
It had two arms (groups): Vasopressin, Arginine, ADH (experimental) and Sterile Salilne (placebo comparator).
Sterile saline will be administered intranasally and emotional responses to facial stimuli measured.
The registry classes the interventions as drug.
More on the Plan
If you decide to participate you will sign this informed consent and Dr.
Price will ask you questions about your medications, medical history, and how you are feeling on that particular day.
You will be asked to complete a questionnaire regarding Childhood Trauma and a Brief Psychiatric Rating Scale.
You will undergo a brief physical examination which includes an EKG (to look at your heart function), blood pressure and pulse by Dr.
Who Took Part
Enrollment: 225 actual participants took part.
It was open to people of any sex aged from 18 years up to 30 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: individuals with high blood pressure or a history of seizures; heart problems; psychiatric problems.
How the Study Was Run
It was run as a randomized, crossover and double-blind study.
Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.
Each person switched between Vasopressin and the comparison at some point, usually with a gap in between.
As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2011-09 with completion listed for 2015-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Emotional Responses (time frame: 60 min).
It also tracked 1 secondary outcome, for example Genetic contributions.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Vasopressin in 225 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vasopressin compound page, all human trials.
Our Notes on the Compound
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
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.