|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 11, 2006 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Primary outcome measure will be the mean change from baseline in the RLS scale at week 2 following placebo/BTX injections | ||||||||
| Change History | Complete list of historical versions of study NCT00325065 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Identifying the Role of Oxytocin and Vasopressin in the Functioning of Neurocognitive Systems Involved in Mood Disorders | ||||||||
| Official Title ICMJE | Identifying the Role of Oxytocin and Vasopressin in the Functioning of Neurocognitive Systems Involved in Mood Disorders | ||||||||
| Brief Summary | The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate, respectively, the effective processing of aversive signals. Moreover, we wish to examine whether increased vasopressin levels will increase, and increased oxytocin levels decrease, the neural response in the amygdala and other limbic structures to aversive stimuli. In addition, we wish to assess whether OT and AVP administration will lead to the facilitation of conspecific recognition as appears to be the case for other mammalian species.... |
||||||||
| Detailed Description | Objective: The goal of this protocol, broadly stated, is to use targeted manipulations with intranasally administered oxytocin (OT) and arginine vasopressin (AVP) in conjunction with neurocognitive and neuroimaging paradigms to evaluate claims that OT and AVP inhibit and facilitate, respectively, the effective processing of aversive signals. Study Population: A total of 216 healthy male and female adults between 20-40 years of age. Design: This protocol will involve a series of independent studies. Each study will require one visit in addition to a screening visit, involves a physical and psychiatric assessment. The study visit itself will involve pharmacological challenge followed by neurocognitive or neuroimaging testing. Outcome Measures: Moreover, we wish to examine whether increased vasopressin levels will increase, and increased oxytocin levels decrease, the neural response in the amygdala and other limbic structures to aversive stimuli. In addition, we wish to assess whether OT and AVP administration will lead to the facilitation of conspecific recognition as appears to be the case for other mammalian species. |
||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Mood Disorders | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 216 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
EXCLUSION CRITERIA: Because factors such as psychiatric disease or CNS disease can influence functional brain activity, these factors are exclusionary.
ADDITIONAL EXCLUSION CRITERIA FOR FMRI STUDIES:
|
||||||||
| Gender | Both | ||||||||
| Ages | 20 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00325065 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 060155, 06-M-0155 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | August 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||