Trial · Interventional

CompletedPhase 2Results postedRegistry data

Deciphering the Role of Oxytocin in Motivation: an fMRI Study

NCTNCT01722071Other idUL1RR024986

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 20 participants (actual)
Sponsor: Tiffany Love · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Oct 2012
Primary completion: Sept 2013
Completion: Oct 2015
First posted: 6 Nov 2012 (estimated)
Last update posted: 29 Jan 2016 (estimated)
Conditions: Focus of Study: Neural Correlates of Oxytocin Administration

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20122013201420152016

Ph 2
Deciphering the Role of Oxytocin in Motivation: an fMRI Study
NCT01722071
Oct 2012 to Oct 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

PlaceboDrug
OxytocinDrug

Arms2

Placebo comparator
Placebo
Each participant will be studied using fMRI following self-administration of placebo.
Experimental
Oxytocin
Each participant will be studied using fMRI following self-administration of oxytocin.

Primary outcomes1

Outcomes the sponsor listed as primary.

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
Time frame · Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Registry description
Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions. Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis. Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).

Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.

Group	Value (BOLD signal change (beta values))	Spread
Placebo Then Oxytocin	0.7944	0.3252
Oxytocin Then Placebo	0.5790	0.2515

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo Then OxytocinEach participant will be studied using fMRI following self-administration of placebo. Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.	–	0 / 10	0 / 10
Oxytocin Then PlaceboEach participant will be studied using fMRI following self-administration of oxytocin. Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.	–	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

4 results

Oxytocin modulates hemodynamic responses to monetary incentives in humans.

Mickey et al. 2016Psychopharmacologycited by 23

PMID 27614896PMC5106343DOI 10.1007/s00213-016-4423-6PUB-27614896

Rights unknown4 results

Source link See results (4)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 20 Years up to 35 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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