SchizophreniaNCT03662425
Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms
A study testing Oxytocin and Saline in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 55 years;
- DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.
Who cannot join
- presence of other psychiatric diagnoses (e.g., depression);
- active misuse of substance or alcohol;
- intellectual disability (IQ < 70);
- a history of neurological disorder.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, Saline
- Keywords
- schizophrenia, negative symptoms, oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
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
SalineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia with oxytocin | Experimental | 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. Receives: Drug: Oxytocin |
| schizophrenia with Placebo | Placebo comparator | 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
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.
Measured: baseline
The Positive and Negative Syndrome Scale (PANSS)
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.
Measured: the two-week endpoint
The Clinical Assessment Interview for Negative Symptoms (CAINS)
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.
Measured: baseline
The Clinical Assessment Interview for Negative Symptoms (CAINS)
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.
Measured: the two-week endpoint
Secondary outcomes (10)
Reinforcement Learning Task
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.
Measured: baseline
Reinforcement Learning Task
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.
Measured: the two-week endpoint
The Temporal Experience of Pleasure Scale (TEPS)
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.
Measured: baseline
The Temporal Experience of Pleasure Scale (TEPS)
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.
Measured: the two-week endpoint
Interpersonal Reactivity Index (IRI)
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.
Measured: baseline
Interpersonal Reactivity Index (IRI)
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.
Measured: the two-week endpoint
Toronto Alexithymia Scale (TAS)
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.
Measured: baseline
Toronto Alexithymia Scale (TAS)
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.
Measured: the two-week endpoint
emotion recognition task
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).
Measured: baseline
emotion recognition task
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).
Measured: the two-week endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start21 Jul 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Zhenghui Yi, Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662425
- Sponsor's protocol ID
- KLMH2018K02
- Status last verified
- Apr 2020
- First submitted
- 27 Jun 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Behavioral Mechanisms
- ClinicalTrials.gov ID
- NCT03662425
- Acronym / sponsor ID
- KLMH2018K02
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, negative symptoms, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia with oxytocin | Experimental | Drug: OxytocinParticipants 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. |
| schizophrenia with Placebo | Placebo comparator | Drug: SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged between 18 and 55 years;
- DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.
Key exclusion criteria (4 listed)
- presence of other psychiatric diagnoses (e.g., depression);
- active misuse of substance or alcohol;
- intellectual disability (IQ < 70);
- a history of neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinIt'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 | Drug | schizophrenia with oxytocin |
| SalineIt'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 | Drug | schizophrenia with Placebo |
Primary outcome
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.
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 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.
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.
10 secondary outcomes
Reinforcement Learning Task
Time frame: baseline
Reinforcement Learning Task
Time frame: the two-week endpoint
The Temporal Experience of Pleasure Scale (TEPS)
Time frame: baseline
The Temporal Experience of Pleasure Scale (TEPS)
Time frame: the two-week endpoint
Interpersonal Reactivity Index (IRI)
Time frame: baseline
Interpersonal Reactivity Index (IRI)
Time frame: the two-week endpoint
Toronto Alexithymia Scale (TAS)
Time frame: baseline
Toronto Alexithymia Scale (TAS)
Time frame: the two-week endpoint
emotion recognition task
Time frame: baseline
emotion recognition task
Time frame: the two-week endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenghui Yi, Ph.D principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Saline in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.