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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Oxytocin Add-on Study for Stable Anxiety Patients

Overview

Status
Terminated
Phase
Not applicable
Enrollment
17 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Feb 2009
Primary completion
Apr 2011
Completion
Apr 2011
First posted
6 Oct 2009 (estimated)
Last update posted
25 Sept 2019
Conditions
Anxiety Disorders

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. N/A

    Oxytocin Add-on Study for Stable Anxiety Patients

    NCT00989937

    Feb 2009 to Apr 2011

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Group 1

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

  • Placebo comparator

    Group 2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Performed at each visit (weekly)

Secondary outcomes(11)
  1. Clinical Global Impression - Severity of Illness (CGI-S

    Time frame · Performed at each visit (weekly)

  2. Clinical Global Impression - Global Improvement (CGI-I

    Time frame · Performed at each visit (weekly)

  3. Social Phobia Inventory (SPIN)

    Time frame · Performed at each visit (weekly)

  4. The State-Trait Anxiety Inventory (STAI)

    Time frame · Performed at each visit (weekly)

  5. The Profile of Mood States (POMS)

    Time frame · Performed at each visit (weekly)

  6. Sheehan Disability Scale (SDS)

    Time frame · Performed at each visit (weekly)

  7. Arizona Sexual Experience Scale (ASEX)

    Time frame · Performed at each visit (weekly)

  8. Hamilton-Depression Scale (HAM-D)

    Time frame · Performed at each visit (weekly)

  9. Reading Trust in the Mind in the Eyes Test (RTET)

    Time frame · Visits 1, 4, 5, 8

  10. Childhood Trauma Questionnaire [CTQ]

    Time frame · Visit 1 (only once)

  11. Global Assessment of Functioning (GAF)

    Time frame · Performed at each visit (weekly)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Performed at each visit (weekly)

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

GroupValue
All Participantsnot posted
Secondary and other outcome results(7)
Secondary outcome· Performed at each visit (weekly)

Clinical Global Impression - Severity of Illness (CGI-S

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

Clinical Global Impression - Global Improvement (CGI-I

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

Social Phobia Inventory (SPIN)

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

The State-Trait Anxiety Inventory (STAI)

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

The Profile of Mood States (POMS)

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

Sheehan Disability Scale (SDS)

GroupValue
All Participantsnot posted
Secondary outcome· Performed at each visit (weekly)

Arizona Sexual Experience Scale (ASEX)

GroupValue
All Participantsnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All Participants0 / 00 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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