The effect of oxytocin in PTSD

• Conditions: Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV; MedDRA version: 14.1Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-001288-58-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-27
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18 – 65 years
• Capable to read and comprehend the Dutch language
• Eligibility for MRI (i.e. no metals, pacemakers or claustrophobia)
• Exposed to a potentially traumatic event, according to PTSD A1 criterion in the DSM-IV (minimal 1 month ago), quantified as a score of 1 or higher on the Life Events Checklist (LEC).
PTSD patients:
• Current PTSD diagnosis
• CAPS score = 45
Traumatized healthy controls:
• CAPS-score < 15

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any severe or chronic systemic disease
• Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation
• Current severe depressive disorder
• Prominent current suicidal risk or homicidal ideation
• Severe cognitive impairment or a history of organic mental disorder
• History of neurological disorders (e.g., traumatic brain injury, seizure history)
• Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma)
• Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative such as cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year
• Use of certain medication: prostaglandins, certain anti-migraine medications (ergot alkaloids), ß-adrenergic receptor-blocking agents, systemic glucocorticoids and psychopharmacological medication.
• Sensitivity or allergy for OT or its components (e.g. methylhydroxybenzoate and propylhydroxybenzoate)
• Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
Traumatized healthy controls only:
• (lifetime history of) PTSD diagnosis, major depressive disorder.
• current DSM-IV axis 1 disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified