Status:
TERMINATED
Oxytocin Add-on Study for Stable Anxiety Patients
Lead Sponsor:
University of California, San Diego
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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.
Detailed Description
Anxious patients treated with even the best currently available anti-anxiety drugs continue to experience significant symptoms. A variety of basic science, animal studies, and human studies support t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00989937
Start Date
February 1 2009
End Date
April 1 2011
Last Update
September 25 2019
Active Locations (1)
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1
UCSD Medical Center
San Diego, California, United States, 92103