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Study on the Effects of GT-002 and Oxazepam for Cognitive Impairment in Schizophrenia Patients

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called GT-002 on individuals with schizophrenia and related disorders. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. The study will also involve a medication called oxazepam, which is commonly used to treat anxiety, and a placebo, which looks like the real medication but contains no active ingredients.

The purpose of the study is to explore how GT-002 affects certain brain activities in people with schizophrenia. Participants will receive either GT-002, oxazepam, or a placebo and will undergo tests to measure changes in brain function and mood. These tests include monitoring brain waves using a method called EEG, which records electrical activity in the brain, and other assessments to understand how the treatment impacts thinking and attention.

The study will take place over a short period, and participants will be closely monitored for any side effects or changes in their condition. The goal is to gather information on the safety and effectiveness of GT-002 in improving cognitive function in people with schizophrenia, which could lead to better treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include a review of your medical history and a physical examination.
You will also be informed about the trial procedures, and any questions you have will be addressed. Consent will be obtained to ensure you understand the trial and agree to participate.
Step 2
Baseline assessments
Before starting the treatment, baseline assessments will be conducted. These assessments will include various tests to measure your current health status and cognitive function.
The results of these assessments will serve as a reference point to evaluate the effects of the treatment during the trial.
Step 3
Treatment phase
During the treatment phase, you will receive one of the following: GT-002, oxazepam, or a placebo. The placebo is a substance that looks like the medication but does not contain any active ingredients.
The GT-002 is administered as a 1 mg soft capsule taken orally. The oxazepam is provided in tablet form, also taken orally. The exact dosage and frequency will be determined by the study protocol and communicated to you by the study team.
This phase will last for a specified duration, during which you will be required to take the medication as instructed.
Step 4
Follow-up assessments
After the treatment phase, follow-up assessments will be conducted to evaluate the effects of the treatment. These assessments will include similar tests to those conducted at baseline to compare any changes in your health and cognitive function.
You will also be monitored for any side effects or adverse reactions to the treatment.
Step 5
Final visit
At the end of the trial, a final visit will be scheduled. During this visit, you will undergo a comprehensive evaluation to ensure your well-being and to discuss the overall outcomes of your participation in the trial.
Any remaining questions or concerns you have will be addressed, and you will receive information about any further steps if necessary.

Who can join the trial?

8 criteria

Must be legally competent, meaning you have the legal capacity to make decisions for yourself.
Must be a male or a non-pregnant, non-breastfeeding female.
Must be between the ages of 18 and 45 years old.
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If you are a healthy control (a person without the condition being studied):
- You must not have any current or past diagnosed mental disorder.
- You must not have a first-degree relative (like a parent or sibling) with a major psychiatric disorder, which means they have not received medical treatment or been hospitalized for such conditions.
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  If you are a patient (a person with the condition being studied):
  - You must meet the diagnostic criteria for schizophrenia or related disorders.
  - You must have been treated with a single antipsychotic medication for at least the last three months. This includes medication taken as needed, and it is preferred if you are treated with medications that partially activate dopamine receptors.
  - You must be clinically stable for at least the last three months, meaning no hospitalizations for schizophrenia or recent increases in psychiatric care.

Who cannot join the trial?

3 criteria

Patients who do not meet the diagnostic criteria for certain mental health conditions like schizophrenia or related disorders cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Investigated drugs

GT-002 is a medication being studied for its potential effects on the brain, specifically in people with schizophrenia. Schizophrenia is a mental health condition that can affect how a person thinks, feels, and behaves. This medication works by partially affecting a part of the brain called the GABA(A) receptor. The GABA(A) receptor is involved in controlling brain activity, and by modulating it, GT-002 may help improve certain brain functions that are often impaired in people with schizophrenia. The trial aims to see if GT-002 can help with cognitive issues, like problems with thinking and memory, that are common in schizophrenia. Researchers are looking at how this medication affects brain activity using special tests that measure brain waves and muscle responses.

What is already known about the treatment

GT-002 – GT-002 is administered orally and is currently being studied in clinical trials for its potential benefits in treating cognitive impairments associated with schizophrenia and related disorders. This medication is in the research phase, specifically in a Phase II clinical trial, and is not yet widely available in medical practice. It is primarily aimed at helping individuals with schizophrenia, persistent delusional disorder, and other related psychotic disorders. GT-002 works by partially modulating the GABA(A) receptors in the brain, which are involved in regulating brain activity and are thought to play a role in the cognitive challenges faced by people with these conditions. It falls under the pharmacological classification of GABA receptor modulators.

Investigated diseases

Schizophrenia
Schizophrenia is a chronic mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It often manifests through hallucinations, delusions, and disorganized thinking. Over time, individuals may experience a decline in cognitive functions, affecting memory, attention, and problem-solving abilities. The progression can lead to difficulties in maintaining personal relationships and employment. Symptoms can fluctuate, with periods of exacerbation and remission. The exact cause is unknown, but it involves a combination of genetic, brain chemistry, and environmental factors.
Persistent Delusional Disorder
Persistent Delusional Disorder is a mental health condition marked by the presence of one or more delusions that persist for at least one month. These delusions are typically non-bizarre, meaning they involve situations that could occur in real life, such as being followed or having a disease. Unlike schizophrenia, hallucinations are not prominent, and cognitive functioning remains relatively intact. The disorder can lead to significant distress or impairment in social, occupational, or other important areas of functioning. The delusions are often resistant to change, even when presented with evidence to the contrary. The cause is not well understood but may involve a combination of genetic, psychological, and environmental factors.
Acute and Transient Psychotic Disorders
Acute and Transient Psychotic Disorders are characterized by the sudden onset of psychotic symptoms such as delusions, hallucinations, and disorganized speech or behavior. These symptoms appear rapidly and can be severe, but they typically last less than a month. The disorder often follows a stressful event or situation, and individuals may experience confusion and emotional turmoil. Recovery is usually quick, with a return to normal functioning after the episode resolves. The exact cause is unclear, but it may involve stress, genetic predisposition, and other psychological factors. The disorder is distinct from schizophrenia due to its brief duration and sudden onset.
Induced Delusional Disorder
Induced Delusional Disorder, also known as shared psychotic disorder, occurs when an individual develops delusions as a result of a close relationship with another person who already has a delusion. The delusions are typically similar or identical to those of the primary affected person. This condition is often seen in individuals who are socially isolated and have a close emotional bond with the person who has the original delusion. The disorder can lead to significant distress and impairment in daily functioning. It is rare and usually resolves when the individuals are separated. The underlying mechanisms are not well understood but may involve psychological and social factors.
Schizoaffective Disorder
Schizoaffective Disorder is a mental health condition that features symptoms of both schizophrenia and mood disorders, such as depression or bipolar disorder. Individuals experience psychotic symptoms like hallucinations or delusions, along with mood disorder symptoms such as depression or mania. The disorder can lead to difficulties in managing emotions, thinking clearly, and maintaining relationships. Symptoms can vary in intensity and may occur simultaneously or in cycles. The cause is believed to be a combination of genetic, biochemical, and environmental influences. It is distinct from schizophrenia and mood disorders due to the presence of both psychotic and mood symptoms.
Other Non-Organic Psychotic Disorders
Other Non-Organic Psychotic Disorders encompass a range of psychotic conditions that do not have a clear organic or physical cause. These disorders are characterized by symptoms such as delusions, hallucinations, and disorganized thinking. The symptoms can vary widely in severity and duration, affecting an individual's ability to function in daily life. The disorders are typically diagnosed when symptoms do not fit the criteria for more specific psychotic disorders like schizophrenia. The exact causes are not well understood but may involve genetic, psychological, and environmental factors. Treatment focuses on managing symptoms and improving quality of life.