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the Effects of Oxytocin on Negative Symptoms and Cognitive Tasks in Schizophrenia and it's Possible Mechanisms.

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ClinicalTrials.gov Identifier: NCT03662425
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
The purpose of this study was to investigate the effects of oxytocin on negative symptoms and cognitive task performance in schizophrenia. We conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia. We hypothesize that PANSS scores will decline significantly and several social cognition measures will improved significantly or nearly significantly in oxytocin but not placebo recipients. We will collect blood samples and MRI data of patients to explore the mechanism of oxytocin . we will also recruit some age- and Intelligence quotient-matched control subjects, give them a single dose of oxytocin to compare the effects of oxytocin in patients and health subjects.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Oxytocin Drug: Saline Not Applicable

Detailed Description:
Social impairment is a primary cause of disability in schizophrenia, responds poorly to current antipsychotic medications and is related to deficits in social cognitive abilities, which include Theory of Mind, emotion recognition and attributional style. Oxytocin (OT) has many pro-social effects in animals and antipsychotic-like efficacy in preclinical tests. In this study, We conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia. We will recruit 52 patients, Screening of subjects included a review of psychiatric and medical history, physical examination, and blood for standard laboratory tests, baseline social cognition measures were obtained followed by psychiatric ratings. Daily intranasal treatments were initiated after baseline assessments. Social cognition measures and psychiatric ratings were repeated beginning 50 min after the morning dose of study medication on treatment day 14. psychiatric ratings include The Positive and Negative Syndrome Scale (PANSS) and The Clinical Assessment Interview for Negative Symptoms (CAINS). The social cognition instruments are some social scales such as Toronto Alexithymia Scale ,and some computer tests such as Reinforcement Learning Task. We will collect blood samples and MRI data of patients to explore the mechanism of oxytocin. To compare the effects of oxytocin on social behaviors in patients with schizophrenia and in health controls , we will also recruit some age- and IQ-matched control subjects. We will give them a single dose of oxytocin , Behavioral tasks will begin 45 minutes after substance administration

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Effects of Oxytocin on Negative Symptoms of Schizophrenia and Its Behavioral and Neurobiological Mechanisms
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: schizophrenia with oxytocin Drug: Oxytocin
It's a two-week treatment trial.Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of OT spray containing approximately 24 international units of OT

Placebo Comparator: schizophrenia with Placebo Drug: Saline
It's a two-week treatment trial. Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of saline spray containing approximately 24 international units of saline

Experimental: healthy controls with oxytocin Drug: Oxytocin
Subjects self-administer a single dose of oxytocin ,it consists of six 0.1 ml insufflations (alternating between the left and right nostril) of OT spray containing approximately 24 international units of oxytocin

Placebo Comparator: healthy controls with Placebo Drug: Saline
Subjects self-administer a single dose of saline ,it consists of six 0.1 ml insufflations (alternating between the left and right nostril) of saline spray containing approximately 24 international units of saline




Primary Outcome Measures :
  1. The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: the baseline ]
    a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale

  2. The Positive and Negative Syndrome Scale (PANSS) [ Time Frame: the end of second week ]
    a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of

  3. The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the baseline ]
    including CAINS and CAINS self-reported checklists

  4. The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: the end of second week ]
    including CAINS and CAINS self-reported checklists


Secondary Outcome Measures :
  1. Reinforcement Learning Task [ Time Frame: baseline and two weeks ]
    The learning task was administered via commercially available software and was run on a laptop computer . Participants were presented with 4 pairs of landscape items, 1 pair at a time.Two pairs involved potential gain; if the correct item was selected, participants saw an image of a nickel coupled with the word "Win!," whereas if the incorrect item was selected, they saw "Not a winner, Try again!" Two other pairs involved learning to avoid losses; in these pairs, selection of the correct response received the feedback "Keep your money!," whereas selection of the incorrect item resulted in the feedback "Lose!"Following training, the transfer test phase was presented.In these 64 trials, the original 4 training pairs were each presented 4 times, and the 24 novel pairings were each presented twice.Participants were instructed to pick the item in the pair that they thought was "best" based on their earlier learning.

  2. The Temporal Experience of Pleasure Scale (TEPS) [ Time Frame: baseline and two weeks ]
  3. Interpersonal Reactivity Index (IRI) [ Time Frame: baseline and two weeks ]
  4. Toronto Alexithymia Scale (TAS) [ Time Frame: baseline and two weeks ]

Other Outcome Measures:
  1. emotion recognition task [ Time Frame: baseline and two weeks ]
    a computer test in which subjects should indicate which word best describes the emotion in the face presented on the screen.

  2. yoni task [ Time Frame: baseline and two weeks ]
    a computer test measuring theory of mind



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The diagnosis of schizophrenia according to DSM-V
  • patients at an age between 18~55 years old of Han nationality

Exclusion Criteria:

  • other psychiatric diagnoses
  • Suffering from serious physical disease and can not accept the treatment
  • Patients to be diagnosed according to DSM-V for substance abused, development delayed
  • Inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion
  • IQ<70
  • claustrophobic
  • metal implantation in vivo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662425


Contacts
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Contact: Zhenghui YI, Ph.D 86-021-52219023 yizhenghui1971@163.com

Sponsors and Collaborators
Shanghai Mental Health Center
Chinese Academy of Sciences

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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03662425     History of Changes
Other Study ID Numbers: KLMH2018K02
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
schizophrenia
negative symptoms
Oxytocin
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs