Stanford Depression Research Clinic Currently Recruiting for the CORAL STUDY

July 26, 2021 | 12:00am - 12:00am

Study:

A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of the Investigational Drug Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults with Major Depressive Disorder (MDD)

Study Description:

The CORAL STUDY is a clinical research study comparing the safety and effectiveness of an investigational drug plus an antidepressant to placebo plus an antidepressant in the treatment of MDD. Eligible participants cannot have been treated with an antidepressant in the current depressive episode.

Participation in the study will last approximately 70 days. This includes:

  • A screening period of up to 28 days
  • A 14-day study treatment period with investigational drug or placebo plus an antidepressant
  • A 28-day antidepressant continuation period

Eligible participants will be asked to attend 1 on-site screening visit, 5 on-site visits during the treatment period, and 5 on-site visits throughout the antidepressant continuation period.

Study Details:

Phase: 3

Type: Double-blind, placebo-controlled*

Interventions: investigational drug, placebo

Gender: Female, Male

Minimum age: 18 years

Maximum age: 64 years

Enrollment goal: Approximately 424 patients

Compensation range: Speak with study site for more details

Participation length: Approximately 70 days

* A double-blind clinical research study involves human participants in which neither the participant nor the study doctor knows who is getting the investigational drug or the placebo. A placebo is an inactive substance given to a participant in place of the investigational drug.

 Study Purpose:

The overall goal of the study is to evaluate the safety and effectiveness of the investigational drug plus an antidepressant compared to placebo plus an antidepressant in patients with MDD.

Eligibility Criteria:

 Key inclusion criteria:**

  • Be between the ages of 18 and 64, inclusive
  • Be diagnosed with MDD with symptoms present for at least 4 weeks
  • Willing to delay start of any antidepressant as per protocol
  • Agree to adhere to study requirements, including not participating in night shift work during the study treatment period, and refraining from drugs of abuse and alcohol for the duration of the study

**There are additional eligibility requirements which the study doctor will explain to you.

To learn more or prescreen for the CORAL STUDY, please fill out our online survey , email depressionresearch@med.stanford.edu, or call 650-723-8330.

For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT04476030

Full event information: http://events.stanford.edu/events/919/91946

Location: 401 Quarry Road, Stanford CA

Contact Email: mhchang@stanford.edu