Anxiety DisordersNCT00989937
Oxytocin Add-on Study for Stable Anxiety Patients
A study testing Oxytocin in people with Anxiety Disorders, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Cross-Over Pilot Study of Intranasal Oxytocin in Patients With Anxiety Disorder
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.
Read the 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 the idea that the neuropeptide oxytocin may be effective against anxiety in humans. For example, plasma oxytocin levels may function as an index of central serotonin (5-HT) function in human subjects, and serotonin is well-known to be involved in clinical anxiety disorders. Since oxytocin is released directly from limbic-hypothalamic cells, this response presumably represents a direct central assessment of 5-HT response in limbic-hypothalamus (Lee 2003). In animal models, Ring 2006 examined the effects of oxytocin on both behavioral and autonomic parameters of the anxiety response in male mice using three pharmacologically validated preclinical models of anxiety: the four-plate test (FPT), elevated zero maze (EZM), and stress-induced hyperthermia (SIH). The results from this study provide specific behavioral and autonomic evidence of anxiolytic-like effects for oxytocin. In primates, Emiliano et al 2007 found support for the idea that that SSRIs' therapeutic effects on social affiliation and anxiety may be mediated in part through components of the oxytocin system. Human studies include Kosfeld et al (2005), who demonstrated that oxytocin administered intranasally to healthy human subjects in a double-blind, placebo controlled study increased levels of trust. As well, Kirsch et al (2005) showed that intranasal oxytocin reduced activation of brain circuits involved in fear in human subjects. Finally, Scantamburlo (2007) showed a significant negative correlation between oxytocin and the scored symptoms depression and anxiety. These studies clearly suggest the potential utility of OTR agonism as a therapeutically relevant mechanism of action for novel anxiolytics in both sexes.
Each subject will be enrolled for 6 week treatment period after a screening phase. Study procedures involve weekly clinic visits as an outpatient. Forty patients will be randomly assigned to either 40 International Units (IU) oxytocin twice daily or vehicle placebo. After 3 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa. The study ratio is 1:1. Dose of oxytocin is based upon previous studies in humans showing improvement in psychiatric populations related changes in behavior and brain function (Kosfeld et al, 2005; Kirsch 2005; Heinrich M 2003).
The total study duration for each individual subject will be approximately 7 weeks, which includes up to 21-day screening/wash-out period, a baseline (randomization) visit, three week treatment period, 1 week washout, baseline, and three weeks cross over treatment.
- Conditions
- Anxiety Disorders
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
20 IU BID or 40 IU BID
PlaceboDrug
20 IU BID or 40 IU BID
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Hamilton Anxiety Scale (HAM-A)
Measured: Performed at each visit (weekly)
Secondary outcomes (11)
Clinical Global Impression - Severity of Illness (CGI-S
Measured: Performed at each visit (weekly)
Clinical Global Impression - Global Improvement (CGI-I
Measured: Performed at each visit (weekly)
Social Phobia Inventory (SPIN)
Measured: Performed at each visit (weekly)
The State-Trait Anxiety Inventory (STAI)
Measured: Performed at each visit (weekly)
The Profile of Mood States (POMS)
Measured: Performed at each visit (weekly)
Sheehan Disability Scale (SDS)
Measured: Performed at each visit (weekly)
Arizona Sexual Experience Scale (ASEX)
Measured: Performed at each visit (weekly)
Hamilton-Depression Scale (HAM-D)
Measured: Performed at each visit (weekly)
Reading Trust in the Mind in the Eyes Test (RTET)
Measured: Visits 1, 4, 5, 8
Childhood Trauma Questionnaire [CTQ]
Measured: Visit 1 (only once)
Global Assessment of Functioning (GAF)
Measured: Performed at each visit (weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Break in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Feifel, University of California, San Diego
- Investigators
- David Feifel, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989937
- Sponsor's protocol ID
- Oxytocin Anxiety
- Status last verified
- Aug 2019
- First submitted
- 5 Oct 2009
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Cross-Over Pilot Study of Intranasal Oxytocin in Patients With Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00989937
- Acronym / sponsor ID
- Oxytocin Anxiety
- Conditions
- Anxiety Disorders
- Keywords
- oxytocin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Break in funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the idea that the neuropeptide oxytocin may be effective against anxiety in humans. For example, plasma oxytocin levels may function as an index of central serotonin (5-HT) function in human subjects, and serotonin is well-known to be involved in clinical anxiety disorders. Since oxytocin is released directly from limbic-hypothalamic cells, this response presumably represents a direct central assessment of 5-HT response in limbic-hypothalamus (Lee 2003). In animal models, Ring 2006 examined the effects of oxytocin on both behavioral and autonomic parameters of the anxiety response in male mice using three pharmacologically validated preclinical models of anxiety: the four-plate test (FPT), elevated zero maze (EZM), and stress-induced hyperthermia (SIH). The results from this study provide specific behavioral and autonomic evidence of anxiolytic-like effects for oxytocin. In primates, Emiliano et al 2007 found support for the idea that that SSRIs' therapeutic effects on social affiliation and anxiety may be mediated in part through components of the oxytocin system. Human studies include Kosfeld et al (2005), who demonstrated that oxytocin administered intranasally to healthy human subjects in a double-blind, placebo controlled study increased levels of trust. As well, Kirsch et al (2005) showed that intranasal oxytocin reduced activation of brain circuits involved in fear in human subjects. Finally, Scantamburlo (2007) showed a significant negative correlation between oxytocin and the scored symptoms depression and anxiety. These studies clearly suggest the potential utility of OTR agonism as a therapeutically relevant mechanism of action for novel anxiolytics in both sexes.
Each subject will be enrolled for 6 week treatment period after a screening phase. Study procedures involve weekly clinic visits as an outpatient. Forty patients will be randomly assigned to either 40 International Units (IU) oxytocin twice daily or vehicle placebo. After 3 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa. The study ratio is 1:1. Dose of oxytocin is based upon previous studies in humans showing improvement in psychiatric populations related changes in behavior and brain function (Kosfeld et al, 2005; Kirsch 2005; Heinrich M 2003).
The total study duration for each individual subject will be approximately 7 weeks, which includes up to 21-day screening/wash-out period, a baseline (randomization) visit, three week treatment period, 1 week washout, baseline, and three weeks cross over treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Oxytocin, Drug: Placebo20 IU BID for the first week, 40 IU BID for the following two weeks, one week washout, 3 week placebo trial |
| Group 2 | Placebo comparator | Drug: Oxytocin, Drug: PlaceboThree week placebo trial, one week washout, 20 IU BID for the fifth week, 40 IU BID for the following two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin20 IU BID or 40 IU BID | Drug | Group 1, Group 2 |
| Placebo20 IU BID or 40 IU BID | Drug | Group 1, Group 2 |
Primary outcome
Total Score on the Hamilton Anxiety Scale (HAM-A)
Time frame: Performed at each visit (weekly)
11 secondary outcomes
Clinical Global Impression - Severity of Illness (CGI-S
Time frame: Performed at each visit (weekly)
Clinical Global Impression - Global Improvement (CGI-I
Time frame: Performed at each visit (weekly)
Social Phobia Inventory (SPIN)
Time frame: Performed at each visit (weekly)
The State-Trait Anxiety Inventory (STAI)
Time frame: Performed at each visit (weekly)
The Profile of Mood States (POMS)
Time frame: Performed at each visit (weekly)
Sheehan Disability Scale (SDS)
Time frame: Performed at each visit (weekly)
Arizona Sexual Experience Scale (ASEX)
Time frame: Performed at each visit (weekly)
Hamilton-Depression Scale (HAM-D)
Time frame: Performed at each visit (weekly)
Reading Trust in the Mind in the Eyes Test (RTET)
Time frame: Visits 1, 4, 5, 8
Childhood Trauma Questionnaire [CTQ]
Time frame: Visit 1 (only once)
Global Assessment of Functioning (GAF)
Time frame: Performed at each visit (weekly)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Feifel, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Anxiety Disorders, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on the Hamilton Anxiety Scale (HAM-A) (time frame: Performed at each visit (weekly)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.