Oxytocin Add-on Study for Stable Anxiety Patients

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. 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).

2. HAM-A total score ≥15 with Item 1 (anxious mood) and Item 2 (tension) scores ≥2 at randomization.

3. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;

4. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.

5. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator

6. Adult men or women, 18 years of age or older.

7. 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.

8. Must be able to use nasal spray

9. Must be able to communicate effectively with the investigator and study coordinator.

10. 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

Exclusion Criteria:

1. Are pregnant or are breastfeeding

2. A urine drug screen at screening that is positive for recent use of illegal drugs or alcohol

3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study

4. 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.

5. Subjects with a score greater than 1 on question #3 "Suicide". suicidal is excluded.

6. Subjects with a total score greater than 17 on the 21 item scale, HAMD, are excluded from participating.

7. 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.