Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms

September 23, 2021 updated by: Shanghai Mental Health Center

Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Behavioral Mechanisms

The purpose of this study was to investigate the effects of oxytocin on negative symptoms and social cognitive task performance in schizophrenia. The investigators 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. The investigators hypothesize that PANSS scores will decline significantly and several social cognition measures will improved significantly or nearly significantly in oxytocin but not placebo recipients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, the investigators 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. The investigators will recruit patients with schizophrenia, screening of subjects included a review of psychiatric and medical history, physical examination, 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, the Interpersonal Reactivity Index(IRI), and some computer tests such as reinforcement learning task and facial emotion identification test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria were:

  1. aged between 18 and 55 years;
  2. DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.

Exclusion criteria were:

  1. presence of other psychiatric diagnoses (e.g., depression);
  2. active misuse of substance or alcohol;
  3. intellectual disability (IQ < 70);
  4. a history of neurological disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: schizophrenia with oxytocin
Participants self-administered the oxytocin twice daily via intranasal route: before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of oxytocin spray containing approximately 24 international units of 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
Participants self-administered the placebo twice daily via intranasal route: before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of oxytocin spray containing approximately 24 international units of 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Positive and Negative Syndrome Scale (PANSS)
Time Frame: baseline
The Positive and Negative Syndrome Scale (PANSS) is a 30-items, 7-point rating scale, the 7 rating points represent increasing levels of psychopathology, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale. The scale scores range from 30 to 210, with higher scores indicating more severe psychotic symptoms.
baseline
The Positive and Negative Syndrome Scale (PANSS)
Time Frame: the two-week endpoint
The Positive and Negative Syndrome Scale (PANSS) is a 30-items, 7-point rating scale, the 7 rating points represent increasing levels of psychopathology, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale. The scale scores range from 30 to 210, with higher scores indicating more severe psychotic symptoms.
the two-week endpoint
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time Frame: baseline
The Clinical Assessment Interview for Negative Symptoms (CAINS) is used to assess negative symptoms, the CAINS is a 13-item interview-based assessment comprising a nine-item "motivation and pleasure" factor (items included recreation, social and vocational expected pleasure and motivation), and a four-item "expression" factor (items included vocal prosody, gestures, facial, and speech). All items were scored on a five-point scale from 0 (no impairment) to 4 (severe deficit).The scale scores range from 0 to 52, with higher scores indicating more severe negative symptoms.
baseline
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time Frame: the two-week endpoint
The Clinical Assessment Interview for Negative Symptoms (CAINS) is used to assess negative symptoms, the CAINS is a 13-item interview-based assessment comprising a nine-item "motivation and pleasure" factor (items included recreation, social and vocational expected pleasure and motivation), and a four-item "expression" factor (items included vocal prosody, gestures, facial, and speech). All items were scored on a five-point scale from 0 (no impairment) to 4 (severe deficit).The scale scores range from 0 to 52, with higher scores indicating more severe negative symptoms.
the two-week endpoint

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reinforcement Learning Task
Time Frame: baseline
The Gain versus Loss-Avoidance (GLA) task is a probabilistic reinforcement learning paradigm involving stimulus pairs in which choices resulted in reward or in loss avoidance.
baseline
Reinforcement Learning Task
Time Frame: the two-week endpoint
The Gain versus Loss-Avoidance (GLA) task is a probabilistic reinforcement learning paradigm involving stimulus pairs in which choices resulted in reward or in loss avoidance.
the two-week endpoint
The Temporal Experience of Pleasure Scale (TEPS)
Time Frame: baseline
The Chinese version of the TEPS contains 20 items, using a 6-point Likert scale (from 1 = very false for me to 6 = very true for me), and measures anticipatory pleasure and consummatory pleasure, with higher scores indicating better pleasure experience.
baseline
The Temporal Experience of Pleasure Scale (TEPS)
Time Frame: the two-week endpoint
The Chinese version of the TEPS contains 20 items, using a 6-point Likert scale (from 1 = very false for me to 6 = very true for me), and measures anticipatory pleasure and consummatory pleasure, with higher scores indicating better pleasure experience.
the two-week endpoint
Interpersonal Reactivity Index (IRI)
Time Frame: baseline
The Interpersonal Reactivity Index (IRI) (Davis, 1983) measures participants' empathic tendencies, it is a 28-item self-report scale measuring empathy and consists of four subscales: perspective taking, fantasy, personal distress, and empathic concern. While the first two subscales index, cognitive empathy, the last two subscales index affective empathy, each item is rated on a 5-point Likert scale ranging from 0 (does not describe me well) to 4 (describes me very well), and higher scores on the IRI-PT and the IRI-EC reflect greater cognitive and emotional empathy, respectively. In the Chinese version of the IRI, 6 items were deleted and 22 items remained (Chan, 1986) and it has been reported to have good reliability and validity in both normal and schizophrenic populations.
baseline
Interpersonal Reactivity Index (IRI)
Time Frame: the two-week endpoint
The Interpersonal Reactivity Index (IRI) (Davis, 1983) measures participants' empathic tendencies, it is a 28-item self-report scale measuring empathy and consists of four subscales: perspective taking, fantasy, personal distress, and empathic concern. While the first two subscales index, cognitive empathy, the last two subscales index affective empathy, each item is rated on a 5-point Likert scale ranging from 0 (does not describe me well) to 4 (describes me very well), and higher scores on the IRI-PT and the IRI-EC reflect greater cognitive and emotional empathy, respectively. In the Chinese version of the IRI, 6 items were deleted and 22 items remained (Chan, 1986) and it has been reported to have good reliability and validity in both normal and schizophrenic populations.
the two-week endpoint
Toronto Alexithymia Scale (TAS)
Time Frame: baseline
The Toronto Alexithymia Scale (TAS-20) is used to assess the severity of alexithymia, it is a 20-item self-report instrument rated on a 5-point Liker-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 20 to 100, with higher scores indicating higher level of alexithymia. The TAS-20 consist of 3 factors: difficulty identifying feelings (DIF); difficulty describing feelings (DDF); externally oriented cognitive style of thinking (EOT). The Chinese version has been shown with having the same factor structure of the original version and has been associated with good internal consistency [15], which was adopted in this study.
baseline
Toronto Alexithymia Scale (TAS)
Time Frame: the two-week endpoint
The Toronto Alexithymia Scale (TAS-20) is used to assess the severity of alexithymia, it is a 20-item self-report instrument rated on a 5-point Liker-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 20 to 100, with higher scores indicating higher level of alexithymia. The TAS-20 consist of 3 factors: difficulty identifying feelings (DIF); difficulty describing feelings (DDF); externally oriented cognitive style of thinking (EOT). The Chinese version has been shown with having the same factor structure of the original version and has been associated with good internal consistency [15], which was adopted in this study.
the two-week endpoint
emotion recognition task
Time Frame: baseline
The facial emotion identification test is used to assess facial emotion identification abilities, in which participants viewed 91 digital pictures of faces selected from the Japanese Female Facial Expression (JAFFE) Database (1998) and were asked to judge which emotion that particular face displayed on the screen was expressing (happy, sad, angry, afraid, surprise, disgusted or neutral).
baseline
emotion recognition task
Time Frame: the two-week endpoint
The facial emotion identification test is used to assess facial emotion identification abilities, in which participants viewed 91 digital pictures of faces selected from the Japanese Female Facial Expression (JAFFE) Database (1998) and were asked to judge which emotion that particular face displayed on the screen was expressing (happy, sad, angry, afraid, surprise, disgusted or neutral).
the two-week endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhenghui Yi, Ph.D, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KLMH2018K02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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