Trial intelligence / Profile preview

Oxytocin in Psychotherapy

NCT01081249Phase 4

Key facts

Status: Completed
Start: Dec 2008
Primary completion: Jul 2012
Countries: 1

Drugs: oxytocin nasal spray
Conditions: anxiety disorder

Overview

Phase 4, randomised, double-blind trial of oxytocin nasal spray in anxiety disorder (2 arms). Primary endpoint: Verbal and Nonverbal Behavior in Therapy Session. Started Dec 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Placebo then Oxytocin
Placebo in Session 1, Oxytocin in Session 2
Oxytocin then Placebo
Oxytocin in Session 1, Placebo in Session 2

Who it enrols

Males 18-65 in current mental health treatment. Excludes schizophrenia, psychosis, autism, Aspergers, active substance use, and high self-harm risk.

Endpoints

Primary

Verbal and Nonverbal Behavior in Therapy Session1-3 months post-study

Secondary

Salivary Cortisol20 min after session
Heart Rate Variability (HRV)continuously from before drug to 20 min after session
Subjective Ratings of Anxiety and Trust of the Therapistafter session

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