Study on the Effectiveness and Safety of NBI-1065845 for Adults with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest in daily activities. The treatment being tested is a medication called NBI-1065845, which is taken in tablet form. The study will compare the effects of this medication to a placebo to determine its effectiveness and safety when used alongside existing antidepressant treatments.

The purpose of the study is to evaluate how well NBI-1065845 can improve symptoms of depression in individuals with MDD. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for a total of 56 days, during which participants will continue their current antidepressant medications while taking the study medication or placebo.

Throughout the study, participants will be monitored to assess changes in their depression symptoms using a tool called the Montgomery-Asberg Depression Rating Scale (MADRS). The study aims to see if there is a significant improvement in depression symptoms by the end of the 56-day period. Additionally, other measures of daily functioning and overall severity of depression will be evaluated to provide a comprehensive understanding of the treatment’s impact.

1 beginning of the trial

Upon joining the study, you will be asked to confirm your understanding and agreement to participate by completing an informed consent form. This ensures that you are aware of the study’s purpose and procedures.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes a face-to-face evaluation using the Mini-International Neuropsychiatric Interview to confirm a diagnosis of major depressive disorder or persistent depressive disorder.

Your current treatment with oral antidepressants will be reviewed to ensure it meets the study’s criteria. An assessment of your response to these treatments will be conducted using the Massachusetts General Hospital – Antidepressant Treatment Response Questionnaire.

3 baseline measurements

Baseline measurements will be taken, including your score on the Hamilton Depression Rating Scale-17 Item, which must be 22 or higher. This will help establish a starting point for evaluating changes during the study.

4 randomization and treatment

You will be randomly assigned to receive either the study medication, NBI-1065845, or a placebo. The medication is in tablet form and is taken orally.

The study medication or placebo will be administered over a period of 56 days. The specific dosage and frequency will be provided by the study team.

5 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor your progress. These include evaluations of your symptoms using the Montgomery-Asberg Depression Rating Scale and other relevant scales.

Your safety and any side effects will be closely monitored by the study team.

6 end of treatment evaluation

At the end of the 56-day treatment period, a final evaluation will be conducted to assess changes in your symptoms and overall condition.

The primary focus will be on the change in your Montgomery-Asberg Depression Rating Scale score from the beginning to the end of the study.

Who Can Join the Study?

Completed informed consent, which means you understand the study and agree to participate.
Must be at least 18 years old at the time of agreeing to participate.
Have a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder. This diagnosis must be confirmed through a face-to-face interview using a specific questionnaire.
Currently receiving oral antidepressant treatment(s) as specified in the study guidelines.
Have had an Inadequate Response (IR) to oral antidepressant treatments during the current episode of depression. This means the treatments did not work well enough, as assessed by a specific questionnaire.
Have a Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score of 22 or higher at the start of the study. This is a questionnaire used to measure the severity of depression.
Willing and able to follow all study procedures and restrictions, according to the study doctor’s opinion.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Major Depressive Disorder cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not willing to comply with the study requirements cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of substance abuse or dependency cannot participate.
Patients who have a history of severe allergic reactions cannot participate.
Patients who have a history of certain psychiatric disorders cannot participate.
Patients who have a history of non-compliance with medical treatments cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Poliklinika Vlatka Cavka d.o.o.	Zagreb	Croatia
Clinic BBP Bozena Pawelczyk	Katowice	Poland
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska	Torun	Poland

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Praglandia s.r.o.	Prague	Czechia
INEP medical s.r.o.	Prague	Czechia
Clintrial s.r.o.	Prague	Czechia
A-Shine s.r.o.	Plzen	Czechia
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Forbeli s.r.o.	Prague	Czechia
Care Clinic Sp. z o.o.	Katowice	Poland
Clinic for psychiatry Sveti Ivan	Zagreb	Croatia
Klinika za psihijatriju Vrapce	Zagreb	Croatia
Ccexfnm Buuwc Klyayxzxjct Pczplhan Ssa z ozkl	Gdansk	Poland
Nrnkjnhfpiyqszmz Pkchhen stioad	Prague	Czechia
Pjuinkten Cjrfohp Pjyxsevmlzdgifz	Bialystok	Poland
Gaxxwbf Lrdnnuoh Pgwyvgxqdjvrhw Ihqczjok Krdmvmnmbbw	Belchatów	Poland
Mdebevpdzo Sueuoiibpczlqoy Peehtgjuxfjhbp Gwnjghj Lahjrbdv Jrsjoj Łksjwyosd	Bialystok	Poland
Pkqdjzbxfvh Gnekmmyuk Smf z opij	Grudziadz	Poland

Trial status

Country	Status	Recruitment Start
Croatia	Recruiting	03.07.2025
Czechia	Recruiting	03.07.2025
Poland	Recruiting	03.07.2025

Trial locations

Investigated drugs:

9-(4-CYCLOHEXYLOXYPHENYL)-7-METHYL-3,4-DIHYDROPYRAZINO[2,1-C][1,2,4]THIADIAZINE 2,2-DIOXIDE

NBI-1065845 is a medication being tested to see if it can help people with Major Depressive Disorder (MDD) feel better when used alongside their regular treatment. This study is looking at how well this medication works to improve symptoms of depression. The goal is to see if people taking this medication feel less depressed compared to those who do not take it. The study measures changes in depression symptoms using a specific scale called the Montgomery-Asberg Depression Rating Scale (MADRS). This medication is being tested to see if it can be a helpful addition to the usual treatments for depression.

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness and a lack of interest in activities once enjoyed. It affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder often involves a range of emotional and physical problems, leading to a decrease in a person’s ability to function at work and home. Symptoms may include changes in appetite or weight, sleep disturbances, fatigue, feelings of worthlessness or guilt, difficulty concentrating, and recurrent thoughts of death. The progression of the disorder can vary, with some individuals experiencing episodes that last for weeks or months, while others may have symptoms that persist for years. The severity and impact of the disorder can fluctuate over time, with periods of remission and recurrence.

Trial ID:

2024-519418-29-00

Protocol code:

NBI-1065845-MDD3024

NCT ID:

NCT06786624

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of NBI-1065845 for Adults with Major Depressive Disorder

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