Coping SkillsNCT01065610
Oxytocin Buffers Stress Response in Individuals With Impaired Coping Abilities
A study testing Oxytocin in people with Coping Skills and Oxytocin, run by University of Osnabrueck.
Trial summary
This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coping Skills, Oxytocin, Stress
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2008to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
Who cannot join
- psychological disorders
- drug abuse
- cigarette smoking
- coronary diseases
- nervous system diseases
About this study
Official title: Oxytocin Buffers Cortisol Responses to Stress in Individuals With Impaired Coping Abilities
This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application.
- Conditions
- Coping Skills, Oxytocin, Stress
- Being tested
- Oxytocin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Intranasal Oxytocin, 24 IU Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coping SkillsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- University of Osnabrueck
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065610
- Sponsor's protocol ID
- Neurolab_RD_001
- Status last verified
- Jan 2010
- First submitted
- 8 Feb 2010
- Last updated
- 9 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Buffers Cortisol Responses to Stress in Individuals With Impaired Coping Abilities
- ClinicalTrials.gov ID
- NCT01065610
- Acronym / sponsor ID
- Neurolab_RD_001
- Conditions
- Coping Skills, Oxytocin, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of OsnabrueckUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinIntranasal Oxytocin, 24 IU |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male
Key exclusion criteria (5 listed)
- psychological disorders
- drug abuse
- cigarette smoking
- coronary diseases
- nervous system diseases
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 |
|---|---|---|
| Oxytocin | Drug | Oxytocin |
| Placebo | Drug | Placebo |
Primary outcome
Salivary Cortisol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Coping Skills and Oxytocin, run by University of Osnabrueck.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary Cortisol. 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 9 Feb 2010.