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OpenTrials
Completed

NCT Number: NCT04158167

Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

To investigate whether 24IU oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion and Exclusion Criteria:

Schizophrenia subjects:

Inclusion criteria

1) Males between 18 and 50 years 2) Diagnosis of DSM-IV schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research Exclusion criteria

  • General impairment in intellectual functioning
  • History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
  • Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
  • Past history of head injury resulting in loss of consciousness or neurosurgery
  • Concomitant severe medical conditions
  • Metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

Inclusion criteria

  • Males between 18 and 50 years
  • Capacity to provide informed consent Exclusion criteria
  • Life-time diagnosis of psychiatric illnesses including substance abuse 2) General impairment in intellectual functioning 3) Past history of head injury resulting in loss of consciousness or neurosurgery 4) Concomitant severe medical or neurological conditions 5) Metal implants or paramagnetic objects or claustrophobia 6) Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.

Treatment and study plan

Oxytocin

Drug

24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced

Primary outcomes

  1. fMRI changes with oxytocin

    Time frame: Upto 90 minutes after administration

    changes in functional brain connectivity

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Official study title

Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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