Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with schizophrenia spectrum disorders, which include schizophrenia and other primary psychotic disorders. The treatment being tested is a nasal spray containing oxytocin, a hormone that is naturally produced in the body and is known to play a role in social bonding and behavior. The study will compare the effects of oxytocin to a placebo, which is a substance with no active medication, to see if it can enhance social skills when used alongside regular psychosocial treatment.

The purpose of the study is to evaluate whether adding oxytocin to the usual psychosocial treatment can improve social skills in individuals with schizophrenia spectrum disorders. Participants in the study will receive either the oxytocin nasal spray or the placebo, in addition to their regular psychosocial treatment. The study will last for a period of 12 weeks, during which the effects of the treatment on social skills and overall functioning will be monitored.

Throughout the study, researchers will assess changes in personal and social performance, as well as other aspects such as quality of life and cognitive function. The goal is to determine if oxytocin can be a beneficial addition to existing treatments for improving social interactions and quality of life for those living with schizophrenia spectrum disorders.

1 joining the study

Upon joining the study, the participant will be required to provide written informed consent. This is necessary before any trial-related activities can begin.

Eligibility is confirmed through a diagnosis of schizophrenia or other primary psychotic disorders, as well as meeting specific criteria related to age, symptoms, and treatment history.

2 initial assessment

An initial assessment will be conducted to establish baseline measurements. This includes evaluating symptoms using the PANSS negative subscale and other relevant scales.

The participant’s current psychosocial treatment regimen will be documented.

3 treatment phase

Participants will be randomly assigned to receive either oxytocin nasal spray or a placebo. The nasal spray is administered as an add-on to the participant’s existing psychosocial treatment.

The dosage of the nasal spray is 40 international units per milliliter, and it will be administered according to the study protocol.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor changes in personal and social performance, as well as other health indicators.

These assessments will occur at specified intervals over the 12-week treatment period.

5 final evaluation

At the end of the 12-week period, a final evaluation will be conducted to assess the overall impact of the treatment on social skills and other health outcomes.

The primary endpoint is the change in the Personal and Social Performance Scale, while secondary endpoints include improvements in psychopathology, social functioning, and quality of life.

Who Can Join the Study?

Age between 18 and 64 years.
Must provide written informed consent before joining the clinical trial. This means you agree to participate after understanding the study details.
Must have a diagnosis of schizophrenia or other primary psychotic disorders confirmed by a specific interview called the MINI-DIPS-OA Interview.
Must have at least one symptom of moderate severity or worse in the PANSS negative subscale. This is a way to measure certain symptoms related to schizophrenia.
Must be receiving psychosocial treatment, either as an inpatient or outpatient, at least twice a week during the study. This means you are getting regular support or therapy.
For male participants and female participants who cannot have children, or female participants who can have children but use a highly effective birth control method approved by health authorities. This includes:
- Women who cannot have children, such as those who are post-menopausal (no periods for 12 months naturally or 6 months with certain hormone levels) or have had surgery to remove ovaries or sterilization.
- Women who can have children must use reliable birth control methods like hormonal contraceptives, an intrauterine device, or a double barrier method. Total abstinence is acceptable if it is ensured by the participant’s age, occupation, lifestyle, or sexual orientation.
- Unreliable methods like calendar methods or withdrawal are not acceptable.
- A reliable method of contraception must be used for the entire duration of the study.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of schizophrenia or other primary psychotic disorders. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Psychotic disorders are mental health conditions that involve losing touch with reality.
Individuals who are not within the specified age range for the study. The age range is typically set to ensure the safety and effectiveness of the treatment for a specific group.
Individuals who are not receiving psychosocial treatment, which is a type of therapy that involves talking with a mental health professional to improve mental health and well-being.
Individuals who are part of a vulnerable population, which means they might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Central Institute of Mental Health	Mannheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	31.03.2024

Trial locations

Investigated drugs:

Oxytocin

Oxytocin is being tested in this trial to see if it can help improve social skills in people with schizophrenia spectrum disorders. It is given as a nasal spray and is used in addition to the usual psychosocial treatment that patients receive. The goal is to determine if adding oxytocin can make the standard treatment more effective.

Psychosocial Treatment refers to the standard care that patients with schizophrenia spectrum disorders receive. This treatment focuses on helping patients improve their social skills and manage their symptoms through therapy and support. In this trial, it is used as the base treatment to which oxytocin is added.

Investigated diseases:

Schizophrenia – Schizophrenia is a chronic mental health disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Individuals with schizophrenia may experience hallucinations, delusions, disorganized thinking, and impaired functioning in daily life. The disorder typically emerges in late adolescence or early adulthood and can vary in severity and progression. Symptoms may fluctuate over time, with periods of exacerbation and remission. Schizophrenia affects personal and social performance, often requiring long-term management and support.

Trial ID:

2023-509433-40-00

Protocol code:

OXY-APS

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Improving Social Skills in Schizophrenia Using Oxytocin or Placebo as an Add-On Treatment for Patients with Schizophrenia Spectrum Disorders

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?