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NCT07196501RECRUITINGIRB Ready

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Sponsored by Neurocrine Biosciences

Quick Self-Assessment

See if you qualify and express your interest

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1 of 550 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Who Can Participate

Inclusion Criteria

Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score โ‰ฅ22 at screening and at study baseline (Day 1).
Willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Key

Exclusion Criteria

A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
Participants depressive symptoms have previously

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

550 participants

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Gender

ALL

๐Ÿข

Sponsor

Neurocrine Biosciences

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Oceanside

California

Location available
View Oceanside location page
RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
RECRUITING

Miami Gardens

Florida

Location available
View Miami Gardens location page
RECRUITING

Orlando

Florida

Location available
View Orlando location page
RECRUITING

Palm Bay

Florida

Location available
View Palm Bay location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

O'Fallon

Missouri

Location available
View O'Fallon location page
RECRUITING

Albuquerque

New Mexico

Location available
View Albuquerque location page
RECRUITING

Charlotte

North Carolina

Location available
View Charlotte location page

๐Ÿ“ And 7 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Major Depressive Disorder Treatment in Melbourne?

Join others in Florida exploring innovative treatment options through clinical research

Major Depressive Disorder Treatment Options in Melbourne, Florida

If you're searching for Major Depressive Disorder treatment in Melbourne, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Melbourne, Miami Gardens, O'Fallon and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Major Depressive Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 550 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Major Depressive Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Major Depressive Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Major Depressive Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07196501. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.