Ongoing Clinical Trials for Schizoaffective Disorder Depressive Type
This article provides information about ongoing clinical trials investigating new treatments for schizoaffective disorder depressive type. Currently, there is 1 active clinical trial testing esketamine, a medication that targets both depressive and negative symptoms in patients with this condition. The trial is being conducted in Austria and is expected to continue until November 2025.
Clinical trial locations
Study on Esketamine and Diphenhydramine for Treating Depression and Negative Symptoms in Schizophrenia Patients
This clinical trial focuses on evaluating the effectiveness of esketamine in treating both negative and depressive symptoms in patients with schizophrenia or schizoaffective disorder. The study compares esketamine to diphenhydramine, which serves as a placebo in this research. Diphenhydramine is commonly known for its use in allergy relief but is used here as a comparison treatment rather than the investigational medication.
Main inclusion criteria:
- Confirmed diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 diagnostic criteria
- Presence of significant negative symptoms with a minimum score of 39 on the Brief Negative Symptom Scale (BNSS), or significant depression with a minimum score of 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- Age between 18 and 65 years
- Ability to provide written informed consent, demonstrating understanding of the study and voluntary agreement to participate
- Stable mental health medication regimen for at least four weeks prior to enrolling in the study
- For women of childbearing potential, use of reliable contraception methods such as oral contraceptives, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, or diaphragm
Main exclusion criteria:
- Absence of a confirmed diagnosis of schizophrenia or schizoaffective disorder
- Lack of negative symptoms, which include decreased emotional expression, reduced motivation, or diminished ability to experience pleasure
- Absence of depressive symptoms such as sadness, hopelessness, or low energy
- Age outside the specified range for the study
- Belonging to a vulnerable population that might be at higher risk of harm or exploitation during the research
Focus and goals:
The study aims to determine whether esketamine is more effective than placebo in reducing negative and depressive symptoms in patients with schizophrenia or schizoaffective disorder. The trial uses a crossover design, meaning participants will receive both treatments at different times during the study period. This approach allows researchers to compare how each participant responds to both esketamine and the placebo.
The trial follows a structured timeline over four weeks. After initial assessment and baseline evaluation, participants enter the first two-week treatment phase where they receive either esketamine or diphenhydramine through intravenous infusion. Following a midpoint evaluation at two weeks, participants switch to the alternative treatment for another two-week period. Those who received esketamine first will then receive diphenhydramine, and vice versa. A final evaluation measures changes in symptoms using the BNSS and MADRS scales.
Investigational drug:
Esketamine is the main medication being investigated in this trial. It works by affecting the brain’s chemical systems, specifically targeting the NMDA receptor, which plays a role in mood regulation. In this study, esketamine is administered as an intravenous solution for injection. The medication is being tested for its potential to reduce both negative symptoms, such as lack of emotion or motivation, and depressive symptoms in patients with schizophrenia or schizoaffective disorder. These symptoms are often difficult to treat with traditional medications, making esketamine a potentially important treatment option if proven effective.
Summary
Currently, there is one active clinical trial investigating new treatments for schizoaffective disorder depressive type. The trial is being conducted in Austria and focuses on esketamine, a medication that works differently from traditional treatments by targeting the NMDA receptor in the brain. This trial is particularly notable because it addresses both negative and depressive symptoms, which are often challenging to manage in patients with schizophrenia spectrum disorders.
The study uses a crossover design, allowing each participant to experience both the investigational treatment and the placebo, which provides more comprehensive data about the medication’s effectiveness. The trial is expected to continue until November 2025, and its results may provide valuable information about new treatment options for individuals living with schizoaffective disorder depressive type who have not found adequate relief with existing therapies.
