Oxytocin Add-on Study for Stable Anxiety Patients

Stopped early · Not applicable · Has a placebo group

Conditions studied: Anxiety Disorders

In brief

The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve anxiety symptoms in patients with a variety of anxiety disorders.

Key facts

Study ID

NCT00989937

Run by

University of California, San Diego

People needed

17

Starts

2009-02-01

Expected to finish

2011-04-01

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Post-traumatic stress disorder, or Anxiety Disorder NOS, confirmed by a semi-structured interview with the Structured Clinical Interview for DSM-IV Axis Disorders-Modified-Patient Edition (SCID).
• HAM-A total score ≥15 with Item 1 (anxious mood) and Item 2 (tension) scores ≥2 at randomization.
• Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;
• Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
• Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator
• Adult men or women, 18 years of age or older.
• Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator). In addition, there must be no clinical information that, in the judgment of a physician, should preclude a subjects' participation at study entry.
• Must be able to use nasal spray
• Must be able to communicate effectively with the investigator and study coordinator.
• Patients may be taking a variety of medications for anxiety at the time of enrollment, or may be receiving no medication treatment, but must be stable on their particular regiment for 3 weeks. If the subject is in the process of changing medications, enrollment will be deferred

You may not qualify if…

• Are pregnant or are breastfeeding
• A urine drug screen at screening that is positive for recent use of illegal drugs or alcohol
• Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
• For any reason the investigator considers the subject to be an unsuitable candidate to receive Oxytocin or believes the subject would be non-compliant with taking the study drug or study procedures.
• Subjects with a score greater than 1 on question #3 "Suicide". suicidal is excluded.
• Subjects with a total score greater than 17 on the 21 item scale, HAMD, are excluded from participating.
• Subjects with a diagnosis of Obsessive Compulsive Disorder, a psychotic disorder, bipolar disorder, or with substance abuse or dependence in the prior 6 months will be excluded.

Where it is running

• UCSD Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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