Contact: Developing New Clinical Management Strategies
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/17/2019 |
| Start Date: | January 30, 2019 |
| End Date: | January 23, 2021 |
| Contact: | Stuart Fine, BS |
| Email: | stuart.fine@nyspi.columbia.edu |
| Phone: | 646-774-8670 |
Developing New Clinical Management Strategies for Antidepressant Treatments
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 Depressive Disorder (MDD) and enhanced medication response in open clinical
treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs
radically differs from how antidepressant medications are prescribed in standard clinical
practice and is believed to be a major reason why the majority of studies submitted to the
Food and Drug Administration (FDA) fail to show a significant difference between medication
and placebo. Moreover, a "one size fits all" approach to psychopharmacologic management
(i.e., weekly visits for all patients) does not take into account differences between
patients that may predispose some individuals to respond positively to frequent follow-up
visits, while others may respond negatively or not at all. Clinic visits comprise multiple
components that may be therapeutic for depression, including activating patients' behavior,
exposing them to medical procedures, permitting social interactions with research staff, and
providing supportive meetings with clinicians. Two independent meta-analyses have associated
more frequent study visits with increased antidepressant and placebo response as well as
decreased separation between medication and placebo. Despite the high costs and potential
disadvantages of weekly follow-up visits for patients receiving antidepressant medication,
this clinical management strategy has not been studied prospectively to date. It is unknown
whether weekly follow-up visits are needed to ensure treatment compliance and patient safety
in clinical trials and to what degree contacts with clinicians influence medication and
placebo response.
that will result in improved drug/placebo separation in randomized controlled trials (RCTs)
for Major Depressive Disorder (MDD) and enhanced medication response in open clinical
treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs
radically differs from how antidepressant medications are prescribed in standard clinical
practice and is believed to be a major reason why the majority of studies submitted to the
Food and Drug Administration (FDA) fail to show a significant difference between medication
and placebo. Moreover, a "one size fits all" approach to psychopharmacologic management
(i.e., weekly visits for all patients) does not take into account differences between
patients that may predispose some individuals to respond positively to frequent follow-up
visits, while others may respond negatively or not at all. Clinic visits comprise multiple
components that may be therapeutic for depression, including activating patients' behavior,
exposing them to medical procedures, permitting social interactions with research staff, and
providing supportive meetings with clinicians. Two independent meta-analyses have associated
more frequent study visits with increased antidepressant and placebo response as well as
decreased separation between medication and placebo. Despite the high costs and potential
disadvantages of weekly follow-up visits for patients receiving antidepressant medication,
this clinical management strategy has not been studied prospectively to date. It is unknown
whether weekly follow-up visits are needed to ensure treatment compliance and patient safety
in clinical trials and to what degree contacts with clinicians influence medication and
placebo response.
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 Management" (CFM, every 4 weeks study visits) and antidepressant
medication vs. placebo. Specifying visit frequency as the independent variable in this study
has the distinct advantages of being easily operationalized for research purposes avoiding a
priori assumptions about which components of study visits influence antidepressant and
placebo response (i.e., behavioral activation vs. doctor-patient relationship vs. medical
procedures). Close monitoring of all subjects will be assured by telephone evaluations of
individuals randomized to CFM at intervals between monthly visits, and additional study
contacts will be scheduled as necessary to maintain patient safety (all extra-protocol
contacts will be recorded and included as a variable in outcome analyses). Additionally,
subjects will be characterized extensively on clinical, demographic, and psychological
measures to pilot the study assessment battery and search for predictor variables influencing
the effects of contact frequency on medication and placebo response.
outpatients with MDD to "Research Frequency Management" (RFM, weekly study visits) vs.
"Community Frequency Management" (CFM, every 4 weeks study visits) and antidepressant
medication vs. placebo. Specifying visit frequency as the independent variable in this study
has the distinct advantages of being easily operationalized for research purposes avoiding a
priori assumptions about which components of study visits influence antidepressant and
placebo response (i.e., behavioral activation vs. doctor-patient relationship vs. medical
procedures). Close monitoring of all subjects will be assured by telephone evaluations of
individuals randomized to CFM at intervals between monthly visits, and additional study
contacts will be scheduled as necessary to maintain patient safety (all extra-protocol
contacts will be recorded and included as a variable in outcome analyses). Additionally,
subjects will be characterized extensively on clinical, demographic, and psychological
measures to pilot the study assessment battery and search for predictor variables influencing
the effects of contact frequency on medication and placebo response.
Inclusion Criteria:
- Inclusion Criteria Method of Ascertainment
1. Men and women aged 18-75 years 1. Clinical interview
2. Diagnosis with Diagnostic and Statistical Manual (DSM) V Major Depressive Disorder
(MDD) 2. Clinical interview, Structured Clinical Interview for DSM-V
3. 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
4. Capable of providing informed consent and complying with study procedures 4. Clinical
interview
5. Using appropriate contraceptive method if woman of child-bearing age and not currently
pregnant 5. Clinical interview
Exclusion Criteria:
1. Current comorbid Axis I DSM V disorder other than Mild Substance Use Disorder,
Adjustment Disorder, Anxiety Disorder or Personality Disorder 1. Clinical interview,
SCID
2. Diagnosis of Moderate to Severe Substance Use Disorder within the past 12 months 2.
Clinical interview, SCID, Urine tox
3. present or past history of psychosis, psychotic disorder, mania, or bipolar disorder
3. Clinical interview, SCID
4. baseline HRSD 24-item score > 28 or HRSD suicide item > 2 or baseline HRSD 17-item
score ≥ 25 4. HRSD by trained rater
5. 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
6. Current treatment with psychotherapy, antidepressants, antipsychotics, or mood
stabilizers 6. Clinical interview
7. CGI-Severity score of 6 or greater at baseline 7. CGI based on Clinical interview
8. Acute, severe, or unstable medical illness 8. Clinical interview, Physical Exam,
Screening Labs
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Bret Rutherford, MD
Phone: 646-774-8670
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
Click here to add this to my saved trials
