Oxytocin Add-on Study for Stable Anxiety Patients

NCT00989937 | Terminated Results

• 1 other identifier: Oxytocin Anxiety
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

oxytocin

Outcome Measures

Primary Outcomes (1)

• Total Score on the Hamilton Anxiety Scale (HAM-A)

  Performed at each visit (weekly)

Secondary Outcomes (11)

• Clinical Global Impression - Severity of Illness (CGI-S

  Performed at each visit (weekly)

• Clinical Global Impression - Global Improvement (CGI-I

  Performed at each visit (weekly)

• Social Phobia Inventory (SPIN)

  Performed at each visit (weekly)

• The State-Trait Anxiety Inventory (STAI)

  Performed at each visit (weekly)

• The Profile of Mood States (POMS)

  Performed at each visit (weekly)

Study Arms (2)

Group 1

EXPERIMENTAL

20 IU BID for the first week, 40 IU BID for the following two weeks, one week washout, 3 week placebo trial

Drug: Oxytocin; Drug: Placebo

Group 2

PLACEBO COMPARATOR

Three week placebo trial, one week washout, 20 IU BID for the fifth week, 40 IU BID for the following two weeks

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

20 IU BID or 40 IU BID

Group 1; Group 2

Placebo DRUG

20 IU BID or 40 IU BID

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.

Results Point of Contact

• Title: David Feifel
• Organization: UCSD

dfeifel@kadimanp.com

Study Officials

• David Feifel, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-08

Locations

US (1)