Study on Enhanced Treatment for Schizophrenia, Depression, and Bipolar Disorder Using Esketamine, Bupropion, and Quetiapine for Patients with Initial Treatment Failure

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What is this study about?

This clinical trial is focused on studying the effects of intensified treatment for individuals with schizophrenia, major depressive disorder, and bipolar depression. The study aims to compare the response to a more intensive medication regimen against the usual treatment in patients who have not responded to their initial treatment. The medications being tested include esketamine hydrochloride (Spravato), esketamine, bupropion hydrochloride, quetiapine, sodium valproate, venlafaxine, lamotrigine, ketamine, sertraline, duloxetine, clozapine, escitalopram, and lithium. Some participants may receive a placebo.

The purpose of the study is to see if an early-intensified treatment can improve symptoms more effectively than the standard approach. Participants will be randomly assigned to receive either the intensified treatment or the usual treatment. The study will last for four to six weeks, depending on the specific condition being treated. During this time, participants will receive their assigned treatment and have their symptoms monitored to assess any changes in severity.

This trial is designed for individuals who have experienced a first-time failure with their initial treatment for schizophrenia, major depressive disorder, or bipolar depression. The goal is to determine if a more aggressive treatment approach can lead to better outcomes for these patients. Participants will be closely monitored throughout the study to ensure their safety and to evaluate the effectiveness of the treatments being tested.

1 initial assessment

Upon joining the clinical trial, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of schizophrenia, major depressive disorder, or bipolar depression and ensuring that there has been a first-time treatment failure with the current medication.

2 baseline visit

A baseline visit will be scheduled to evaluate the current severity of symptoms. This will involve completing specific questionnaires and scales to measure symptom levels. This visit is crucial for establishing a starting point for the trial.

3 treatment phase

The treatment phase will last for either four or six weeks, depending on the condition being treated. During this phase, intensified pharmacological treatment will be administered. The medications used may include esketamine (nasal spray), quetiapine, venlafaxine, sertraline, duloxetine, escitalopram, or lithium, among others. The specific medication, dosage, and frequency will be determined by the study protocol and tailored to individual needs.

4 mid-treatment evaluation

A mid-treatment evaluation will occur to assess the progress and any changes in symptom severity. Adjustments to the treatment plan may be made based on this evaluation.

5 final assessment

At the end of the treatment phase, a final assessment will be conducted. This will involve re-evaluating symptom severity using the same scales and questionnaires as the baseline visit. The goal is to measure any changes in symptoms from the start to the end of the trial.

6 follow-up

A follow-up visit may be scheduled to discuss the results of the trial and any further treatment recommendations. This visit ensures that participants receive appropriate care after the trial concludes.

Who Can Join the Study?

  • Participants can be either inpatients (staying in a hospital) or outpatients (not staying in a hospital).
  • Participants must be at least 18 years old and not older than 70.
  • Participants must be willing and able to provide written consent to join the study. If they cannot, a legal guardian can provide consent, but the participant’s opinion will also be considered.
  • Female participants who can have children must agree to use effective birth control during the study.
  • Participants must have a main diagnosis of one of the following conditions: schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features), or bipolar depression (bipolar disorder type I and II currently in a depressive episode). This diagnosis will be confirmed by a structured interview called the Mini International Neuropsychiatric Interview.
  • Participants must currently be experiencing their first treatment failure, meaning their current medication is not working effectively. This medication must have been a first-choice treatment for their main diagnosis and taken for at least 4 weeks at the recommended dose.
  • Participants must have failed their current medication for their current episode of schizophrenia, major depressive disorder, or bipolar disorder, as confirmed by a Clinical Global Impression-Improvement (CGI-I) score of 3 or higher. The CGI-I is a tool used to assess how much a patient’s illness has improved or worsened.
  • Participants and their doctors must plan to change their current medication.
  • Participants must have a certain level of symptom severity (moderate level) and experience difficulties in daily functioning.

Who Cannot Join the Study?

  • Patients with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder, or bipolar disorder type I and II (currently in a depressive episode) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Of Brescia Brescia Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Westfaelische Wilhelms Universitaet Muenster Munster Germany
University Of Frankfurt Frankfurt Germany
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Bobmsesuekurxtz Spsdpvvz Augsburg Germany
Klumzl fkc Pjdayijgidh ukz Pwloctsxlulsap dgu Uywsjntqcoxinrocoqe Metro Mainz Germany
Cjexkos Phqngvqokynco 1ad fomau Cagliari Italy
Ahsjlim Oicdvktnhvf Uvdyrxntqbgla Coqjzckwbgtk Dbgzf Slalkv E Drwuj Swmaoye Dl Trifuj Turin Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
03.07.2023
Germany Germany
Not yet recruiting
03.07.2023
Italy Italy
Not yet recruiting
03.07.2023
Spain Spain
Not yet recruiting
03.07.2023

Trial locations

Intensified Pharmacological Treatment for Schizophrenia is a therapy designed to help people with schizophrenia who did not respond well to their first treatment. This therapy involves using a combination of medications that work together to reduce symptoms like hallucinations, delusions, and disorganized thinking. The goal is to improve the patient’s mental health more effectively than the initial treatment.

Intensified Pharmacological Treatment for Major Depressive Disorder is a treatment plan for individuals with major depressive disorder who did not benefit from their first medication. This approach uses a mix of medications that aim to lift mood, increase energy levels, and reduce feelings of sadness and hopelessness. The treatment is tailored to provide a better response than the standard treatment.

Intensified Pharmacological Treatment for Bipolar Depression is a therapy for people with bipolar disorder who are currently experiencing a depressive episode and did not respond to their first treatment. This therapy includes a combination of medications that help stabilize mood, reduce depressive symptoms, and prevent mood swings. The aim is to achieve a more significant improvement in the patient’s condition compared to the usual treatment.

Investigated diseases:

Schizophrenia – Schizophrenia is a chronic mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It often manifests with symptoms such as hallucinations, delusions, disorganized thinking, and impaired functioning. The progression of schizophrenia can vary, with some individuals experiencing episodes of acute symptoms followed by periods of remission. Over time, cognitive and functional impairments may become more pronounced. The course of the disease can be influenced by various factors, including environmental stressors and genetic predispositions.

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 may experience hallucinations or delusions alongside mood disturbances like depression or mania. The disorder progresses with episodes of mood symptoms that can occur simultaneously with or independently of psychotic symptoms. The frequency and duration of these episodes can vary widely among individuals. Over time, the disorder may lead to challenges in maintaining social and occupational functioning.

Schizophreniform Disorder – Schizophreniform disorder is a mental condition similar to schizophrenia but distinguished by its shorter duration. Symptoms include hallucinations, delusions, disorganized speech, and abnormal behavior, lasting for at least one month but less than six months. The progression involves the sudden onset of symptoms, which may resolve completely or develop into schizophrenia if they persist beyond six months. The disorder can disrupt daily functioning and social interactions during its active phase. Early intervention may influence the course and outcome of the disorder.

Major Depressive Disorder – Major depressive disorder is a mood disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can lead to significant impairments in daily functioning, affecting sleep, appetite, and concentration. The disorder often progresses through episodes that can last weeks or months, with varying severity. Some individuals may experience recurrent episodes throughout their lives. The impact on daily life can be profound, affecting personal, social, and occupational aspects.

Bipolar Disorder Type I – Bipolar disorder type I is a mental health condition marked by extreme mood swings, including manic episodes and, often, depressive episodes. Manic episodes involve elevated mood, increased energy, and impulsive behavior, while depressive episodes are characterized by low mood and energy. The disorder progresses with alternating periods of mania and depression, which can vary in duration and intensity. These mood changes can significantly impact daily functioning and relationships. The frequency and pattern of episodes can differ among individuals.

Bipolar Disorder Type II – Bipolar disorder type II is characterized by mood swings that include hypomanic episodes and major depressive episodes. Hypomanic episodes are less severe than manic episodes and may involve increased energy and activity levels without significant impairment. The disorder progresses with cycles of depression and hypomania, which can affect personal and professional life. Depressive episodes tend to be more frequent and longer-lasting than hypomanic episodes. The condition requires careful management to maintain stability and prevent mood episodes.

Trial ID:
2022-502185-24-00
Protocol code:
INTENSIFY
NCT ID:
NCT05603104
Trial Phase:
Therapeutic confirmatory (Phase III)

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