Is NCT05850689 recruiting in Tampa, FL?

Yes, NCT05850689 is currently recruiting participants at its Tampa, FL location. This major depressive disorder clinical trial is actively enrolling qualified participants.

How do I join the major depressive disorder clinical trial in Tampa?

To join this clinical trial in Tampa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tampa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Major Depressive Disorder Clinical Trial in Tampa, FL

About This Major Depressive Disorder Study in Tampa

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.

Sponsor: Intra-Cellular Therapies, Inc.

Who Can Participate

Inclusion Criteria

Male or female patients between the ages of 18 and 65 years, inclusive;

Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:

The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;

Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;

Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;

Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;

Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.

Currently having an inadequate response (less than 50% improvement) to 2 or more ADTs in the current MDE as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration:

citalopram/escitalopram

levomilnacipran/milnacipran (if locally approved for MDD)

venlafaxine/desvenlafaxine

vortioxetine

Exclusion Criteria

Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;

Bipolar Disorder;

Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:

Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;

Eating disorder;

Substance use disorders (excluding nicotine);

Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;

Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;

The patient experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;

The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;

In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:

At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;

At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;

At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or

The patient is considered to be in imminent danger to him/herself or others.

The patient has a first MDE at age 60 years or older.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT05850689) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Major Depressive Disorder Treatment Options in Tampa, FL

If you're searching for major depressive disorder treatment options in Tampa, FL, this clinical trial (NCT05850689) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced major depressive disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all major depressive disorder clinical trials near you to find additional studies recruiting in your area.

Major Depressive Disorder Clinical Trial in Tampa, FL

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