Negative symptoms in schizophrenia Trials in Disease

Study on Esketamine and Diphenhydramine for Treating Depression and Negative Symptoms in Schizophrenia Patients

This clinical trial is examining whether esketamine can help improve negative symptoms and depression in people diagnosed with schizophrenia or schizoaffective disorder. Negative symptoms refer to a decrease in normal functioning, such as reduced emotional expression, lack of motivation, or loss of interest in activities. These symptoms can be particularly difficult to treat with standard medications.

Who can participate:

• Adults between 18 and 65 years old
• People with a confirmed diagnosis of schizophrenia according to the DSM-5, which is the standard guide doctors use to identify mental health conditions
• Those who have a score of at least 39 on the Brief Negative Symptom Scale, which measures how severe negative symptoms are, or a score of at least 22 on the Montgomery-Åsberg Depression Rating Scale, which measures depression levels
• Individuals who have been taking stable mental health medication for at least four weeks before joining the study
• People able to understand the study and provide written consent to participate
• Women who can become pregnant must use reliable birth control methods such as the pill, vaginal ring, hormonal patch, intrauterine device, condom, or other approved contraception

Who cannot participate:

• People without a diagnosis of schizophrenia or schizoaffective disorder
• Those who do not experience negative symptoms or depressive symptoms
• Individuals outside the specified age range
• People who are part of vulnerable populations who may be at higher risk of harm or exploitation

What the trial involves:

The study compares esketamine to a placebo to determine which is more effective at reducing symptoms. The placebo used in this trial is diphenhydramine, a medication commonly used for allergy relief. Participants will receive treatment through intravenous infusion, which means the medication is delivered directly into a vein.

The trial follows a crossover design, meaning participants will receive both treatments at different times during the study. This allows researchers to compare how each person responds to esketamine versus the placebo. The study includes several phases:

1. Initial assessment: Participants undergo screening to confirm they meet the eligibility requirements, including having a confirmed diagnosis and stable medication use for at least four weeks.
2. Baseline evaluation: Symptoms are measured using standardized scales to establish a starting point for comparison.
3. First treatment phase: Participants receive either esketamine or diphenhydramine through intravenous infusion for two weeks.
4. Midpoint evaluation: Symptoms are measured again to assess changes after the first treatment period.
5. Second treatment phase: Participants switch to the alternative treatment for another two weeks. Those who received esketamine now receive diphenhydramine, and vice versa.
6. Final evaluation: A final assessment measures changes in symptoms to determine the overall effectiveness of each treatment.

About the investigational drug:

Esketamine is a medication that works on the brain's chemical systems, specifically targeting NMDA receptors, which are involved in mood regulation. While esketamine is sometimes administered as a nasal spray, this particular study uses an intravenous form. Researchers believe it may help improve symptoms that have not responded well to traditional treatments. The goal is to observe whether esketamine can reduce negative symptoms like lack of motivation and emotional flatness, as well as depressive symptoms such as sadness and low energy.