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

NCT ID: NCT03662425

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-21
• Study Completion Date: 2020-03-31

Brief 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 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. aged between 18 and 55 years;

2. DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenghui Yi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

KLMH2018K02

Identifier Type: -

Identifier Source: org_study_id