Oxytocin in PTSD: Effectiveness in addition to psychotherapy

• Conditions: Posttraumatic stress disorder; 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: EUCTR2012-003072-39-NL
• Lead Sponsor: Academic Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-16
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients with a diagnosis of chronic PTSD (> 3 months)
-CAPS score of 50
-Age 18-65 years
-Written informed consent
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Suicidal risk.
- Presence of any of the following DSM IV diagnoses, at present or in the past: psychotic disorder incl. schizophrenia, a bipolar disorder, or excessive substance related or eating disorder over the past 6 months.
- Female patients being pregnant (NB. female patients with childbearing potential must have a negative pregnancy test each month).
- Female patients with an active pregnancy wish.
- Female patients giving lactation to their child.
- Diagnosis of current severe depressive disorder (with psychotic features and/or high suicidal intent).
- An organic disorder/cognitive impairment.
- Patients using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-treatment assessment (T0). Psychotropic medication already used at the pre-treatment assessment will be maintained until the post-treatment assessment. No psychotropic medication will be prescribed for participants during the study unless they develop serious depressive symptoms. A medication protocol in accordance with clinical guidelines (A.P.A., 2004; Institute of Medicine (IOM), 2008; National Institute for Clinical Excellence, 2005) will be used.
-Use of prostaglandins and certain anti-migraine medications (ergot alkaloids), systemic glucocorticoids and beta-blockers.
-Sensitivity or allergy for oxytocin or its components (e.g. methylhydroxybenzoaat en propylhydroxybenzoaat)
-Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative, including cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, and stroke or myocardial infarction within the past year.

Study & Design

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