Status:
COMPLETED
Contact: Developing New Clinical Management Strategies
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
University of Haifa
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The goal of this study is to develop new methods of administering antidepressant medications that will result in improved drug/placebo separation in randomized controlled trials (RCTs) for Major Depre...
Detailed Description
This study utilizes a 2 x 2, double-blind, acute, prospective design randomizing adult outpatients with MDD to "Research Frequency Management" (RFM, weekly study visits) vs. "Community Frequency Mana...
Eligibility Criteria
Inclusion
- \- Inclusion Criteria Method of Ascertainment
- Men and women aged 18-75 years 1. Clinical interview
- Diagnosis with Diagnostic and Statistical Manual (DSM) V Major Depressive Disorder (MDD) 2. Clinical interview, Structured Clinical Interview for DSM-V
- 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16 and ≤ 28; 17-item Hamilton Rating Scale for Depression (HRSD) score \< 25 3. HRSD by trained rater
- Capable of providing informed consent and complying with study procedures 4. Clinical interview
- Using appropriate contraceptive method if woman of child-bearing age and not currently pregnant 5. Clinical interview
Exclusion
- Current comorbid Axis I DSM V disorder other than Mild Substance Use Disorder, Adjustment Disorder, Anxiety Disorder or Personality Disorder 1. Clinical interview, SCID
- Diagnosis of Moderate to Severe Substance Use Disorder within the past 12 months 2. Clinical interview, SCID, Urine tox
- present or past history of psychosis, psychotic disorder, mania, or bipolar disorder 3. Clinical interview, SCID
- baseline HRSD 24-item score \> 28 or HRSD suicide item \> 2 or baseline HRSD 17-item score ≥ 25 4. HRSD by trained rater
- History of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current episode 5. Clinical interview
- Current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers 6. Clinical interview
- CGI-Severity score of 6 or greater at baseline 7. CGI based on Clinical interview
- Acute, severe, or unstable medical illness 8. Clinical interview, Physical Exam, Screening Labs
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03812588
Start Date
January 30 2019
End Date
August 1 2021
Last Update
April 21 2022
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032