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Phase 2 N=20 Randomized Double-blind Basic Science

Deciphering the Role of Oxytocin in Motivation: an fMRI Study

Focus of Study: Neural Correlates of Oxytocin Administration

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. — 0.7944; 0.5790; 0.6119; 0.6688 BOLD signal change (beta values) — p=0.890

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo (Drug); Oxytocin (Drug)
Age
Adult · 20+ yrs
Sex
Male
Sponsor
Tiffany Love
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
0.7944; 0.5790; 0.6119; 0.6688 0.890

Summary

The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Eligibility Criteria

Inclusion Criteria

  • Male
  • 20-35 years of age at the time of screening
  • Right-handedness
  • Non-smoking
  • No current or past history of neurological or psychiatric illness, including substance abuse or dependence
  • No acute medical illness
  • Written informed consent obtained from subject

Exclusion Criteria

  • Female
  • Left-handedness or ambidextrous
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Known allergies to oxytocin or to preservatives in the nasal spray
  • Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening
  • Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan)
  • Any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives
  • Neurological illness, abnormal MRI (except if due to technical factors)
  • Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction.
  • Participants currently taking medications including any treatment, current or past with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants and psychostimulant appetite suppressants, or centrally active antihypertensive drugs (e.g., clonidine, reserpine).
  • Treatment within six months with any of the following: hormone use (testosterone, DHEA), antidepressants, opioid drugs.
  • Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
  • Current or past history of substance abuse or dependence
  • Any reported lifetime use of any category of illicit drugs
  • Positive urine drug screen
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01722071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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