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ClinicalTrials.gov Identifier: NCT02082392
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : July 7, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bret Rutherford, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Escitalopram
Enrollment 3
Recruitment Details Recruitment will be coordinated through the Adult and Late Life Depression Research Clinic and will include flyers posted around Columbia University Medical Center (CUMC), information posted on the CUMC internet website, advertisements in local newspapers and on radio stations, and outreach to CUMC clinical staff.
Pre-assignment Details Interested individuals will contact the ALLDRC coordinator, a telephone screening will take place to identify obviously ineligible subjects. Potentially eligible subjects will be scheduled for an evaluation in the ALLDRC, including a clinical interview by a study clinician (psychiatrist or psychologist) and diagnostic rating by trained rater.
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Clinical Frequency Management Research Frequency Management Total
Hide Arm/Group Description

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
46  (11.3) 48  (0) 46.67  (8.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
1
  50.0%
0
   0.0%
1
  33.3%
Male
1
  50.0%
1
 100.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Hamilton Rating Scale for Depression
Time Frame Baseline week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 2 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
25  (4.24) 31  (0)
2.Secondary Outcome
Title Hamilton Anxiety Rating Scale (HARS) 14-item Scale
Hide Description Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0–56, where <17 indi-cates mild severity, 18–24 mild to moderate severity and25–30 moderate to severe.
Time Frame Baseline week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 2 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.5  (7.78) 13  (0)
3.Secondary Outcome
Title CGI Severity and Improvement
Hide Description

scales developed to measure the clinician’s view of subjects’ global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.

7-point scale: 0 = Not assessed 4 = Moderately ill

1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients

Time Frame Baseline week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 2 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
3  (0) 4  (0)
4.Secondary Outcome
Title Treatment Emergent Symptom Scale
Hide Description rating scale for physical symptoms reported during the study. This is a standard means of recording drug-related adverse effects that will allow us to assess whether contact frequency is associated with differences in side effects among study subjects.
Time Frame Baseline week
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title California Pharmacotherapy Alliance Scale (CALPAS)—Clinician Version
Hide Description 24 item Likert scale rating the clinician's assessment of the therapeutic alliance, particularly about medication issues, with the patient. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy. Prior studies using the CALPAS reported an association between therapeutic alliance and outcome, and some studies found alliance mediated the effect of expectancy on depression outcome.
Time Frame Baseline week
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Blind Assessment—Clinician Version
Hide Description Rates clinician's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale
Hide Description rating scale for depressive symptoms based on DSM criteria. A self-report measure for depressive symptoms is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies (e.g., STAR*D) due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Treatment Credibility and Expectancy Scale (CES)
Hide Description 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. For this study, the primary measure of expectancy will be item 4: "By the end of the treatment period, how much improvement in your depressive symptoms do you think will occur?" (0-100%).
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Client Satisfaction Questionnaire 8 (CSQ 8)
Hide Description self-administered scale with items rating respondents’ satisfaction with mental health services they are receiving on a 4 point Likert scale. Use of the CSQ 8 will allow us to determine whether CFM and RFM are associated with differences in participant satisfaction.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Cornell Treatment Preference Index
Hide Description scale used in mental health studies to document the type and strength of patients' treatment preferences. We will use a modified version in this study asking subjects "Based on your experience and how you feel right now, which of the visit frequencies in this study would be your first choice?" The strength of this preference will be measured on a 5-point Likert scale.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Revised Life Orientation Test (LOT-R)
Hide Description scale developed to assess individual differences in generalized optimism versus pessimism. Degree of optimism on this scale has been correlated with the magnitude of placebo response observed in studies of placebo analgesia, and we will determine whether LOT-R scores moderate effects of therapeutic contact.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Schedule for Adaptive and Nonadaptive Personality (SNAP)
Hide Description this questionnaire is a widely used assessment tool for personality disorders that we will also use to identify predictors of response to varying visit frequency.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title California Pharmacotherapy Alliance Scale (CALPAS)—Patient Version
Hide Description 24 item Likert scale rating the patient's assessment of the therapeutic alliance, particularly about medication issues, with the clinician. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Blind Assessment—Patient Version
Hide Description rates subject's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description:

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinical Frequency Management Research Frequency Management
Hide Arm/Group Description

Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4.

Escitalopram

Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders.

Escitalopram

All-Cause Mortality
Clinical Frequency Management Research Frequency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Clinical Frequency Management Research Frequency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinical Frequency Management Research Frequency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bret Rutherford
Organization: New York State Psychiatric Institute
Phone: 6467748660
EMail: brr8@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Bret Rutherford, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02082392     History of Changes
Other Study ID Numbers: #6652
First Submitted: March 6, 2014
First Posted: March 10, 2014
Results First Submitted: April 3, 2017
Results First Posted: July 7, 2017
Last Update Posted: March 1, 2019