Identifying the Role of Oxytocin and Vasopressin in the Functioning of Neurocognitive Systems Involved in Mood Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00325065
First received: May 11, 2006
Last updated: April 17, 2010
Last verified: April 2010
  Purpose

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....


Condition
Mood Disorders

Study Type: Observational
Official Title: Identifying the Role of Oxytocin and Vasopressin in the Functioning of Neurocognitive Systems Involved in Mood Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 71
Study Start Date: May 2006
Estimated Study Completion Date: April 2010
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Age: Participants will be healthy males and females, 20-40 years of age. Approximately equal numbers of males and females will be included in each study.
    2. IQ: IQ, as measured by 4 subscales from the Wechsler Adult Intelligence Scale-Revised (WAIS-R), must be greater than 80. Prior testing in our laboratory has indicated that this cutoff allows for maximally generalizeable results while ensuring that all participants will understand and be able to complete the testing procedures.
    3. Menstrual phase: Female participants will be tested only during the follicular phase of their menstrual cycle (defined as days 6-12 after the first day of the last menstrual period and confirmed using ovulation testing kits).

EXCLUSION CRITERIA:

Because factors such as psychiatric disease or CNS disease can influence functional brain activity, these factors are exclusionary.

  1. Psychiatric history: Participants will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (SCID). All participants will be free of any current or past major affective disorder, psychotic disorder, substance dependence, anorexia, somatoform disorder, or anxiety disorders including specific phobias.
  2. Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza).
  3. Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 85 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
  4. CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness greater than 3 minutes.
  5. Medication status: Currently on regular medication that would interfere with study results. This includes contraceptive hormones, psychotropic medications or benzodiazepines, alpha and beta adrenergic medications, other anti-hypertensive medications, glucocorticoid and mineralocorticoid medications, and medications causing sedation or stimulation. For example, current use of acetaminophen or ibuprofen is permitted, while current use of benadryl or methylphenidate is not.
  6. Pregnancy or Nursing Status: Currently breast feeding or pregnant (as documented by pregnancy testing which will be performed at screening and on the day of the challenge study).

ADDITIONAL EXCLUSION CRITERIA FOR FMRI STUDIES:

  1. Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
  2. Claustrophobia: Participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325065

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00325065     History of Changes
Other Study ID Numbers: 060155, 06-M-0155
Study First Received: May 11, 2006
Last Updated: April 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Amygdala
Emotion
Memory
Threat
Peptides
Neuropeptides
Oxytocin
Vasopressin
Mood Disorder

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Vasopressins
Arginine Vasopressin
Oxytocin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 20, 2014