Purpose

• This is an opportunity for you to assist in developing a new antidepressant medication. • This research study seeks adult patients with unipolar major depression which has not improved sufficiently with at least three previous antidepressant medications. • Eligible patients will receive a trial of a standard antidepressant medication at the outset of the study. • Those not improving sufficiently will discontinue all medications and be admitted to the hospital for a 10-day study of the tolerability and efficacy of a new antidepressant medication. • Participants will receive either the new medication or a placebo, an inert “sugar pill,” for 10 days in the hospital. All participants will then stop taking the study medication and be observed in the hospital for 5 more days. • Even if the new medication were to be helpful, it will not be available for ongoing treatment as it is early in development. • Participants will be amply compensated for the time spent in the hospital. • All participants will then receive standard treatment by a senior Columbia University psychiatrist/psychopharmacologist, specializing in depression, for six months at no cost to you, including for medication. • Please call the Depression Evaluation service at 212-543-5734 for further information or to arrange a confidential in-person screening, at no cost or obligation.

Type of Study: Clinical Trial
Setting of Study: both
Clinical Trials.gov number: NCT00809562
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English

Study Activities

Filling Out Forms
Blood Samples
Blood Samples for DNA
MRI Scan
Provides Payment: Compensation for study related procedures

Eligibility

Ages Eligible for Study: 21 Years - 65 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

Criteria

Inclusion Criteria:
1. Primary diagnosis of Major Depressive Disorder
2. Subjects aged 21-65
3. Subjects must have Treatment Resistant Depression (TRD) as defined by three previous antidepressant treatment failures, and two within the current depressive episode from different classes
4. Minimum baseline (HAM-D) (17 items) score of ≥18
5. Male or non-pregnant, non-lactating females
6. Signs informed consent form
7. Subjects must be willing to be hospitalized on a psychiatric inpatient unit for at least 16 days

Location: Depression Evaluation Service New York State Psychiatric Institute 1051 Riverside Drive, Unit 51 New York, New York 1--32
Clinic: Depression Evaluation Service
Division: Therapeutics

Study chairs or principal investigators:
Patrick J. McGrath M.D., Principal Investigator

Co-investigators:
Jonathan Stewart, M.D.,
David Hellerstein, M.D.,
Deborah Deliyannides ,