NCT03812588

Contact: Developing New Clinical Management Strategies

Completed Phase 4 Results posted Last updated 21 April 2022

What this trial tests

Phase 4 trial testing Escitalopram in Major Depressive Disorder in 29 participants. Completed in 1 August 2021.

Timeline

30 January 2019

Primary endpoint
27 May 2020

1 August 2021

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	29
Start date	30 January 2019
Primary completion	27 May 2020
Estimated completion	1 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Escitalopram (escitalopram) — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 75, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks) Primary · Up to 8 Weeks

Scale for depressive symptoms administered by trained rater. The Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. The scoring is based on the first 24 items of the Hamilton. Sum of the scores of the first 24 items (range from 0 to 74): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression

Group	Value	95% CI
Clinical Frequency Management: Placebo	1.33	± 3.51
Research Frequency Management: Placebo	11.4	± 4.04
Clinical Frequency Management: Escitalopram	5.33	± 13.65
Research Frequency Management: Escitalopram	9.25	± 9.21

Change From Baseline Hamilton Anxiety Rating Scale 14-item Scale Secondary · Up to 8 Weeks

Scale for anxiety symptoms administered by trained rater. The Hamilton Anxiety 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 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Group	Value	95% CI
Clinical Frequency Management: Placebo	3.67	± 2.52
Research Frequency Management: Placebo	4.40	± 4.22
Clinical Frequency Management: Escitalopram	6.50	± 4.95
Research Frequency Management: Escitalopram	3.37	± 4.98

Change From Baseline Clinical Global Impressions Secondary · Up to 8 Weeks

Scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The Clinical Global Impressions 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

Group	Value	95% CI
Clinical Frequency Management: Placebo	1.00	± 1.73
Research Frequency Management: Placebo	1.20	± 0.84
Clinical Frequency Management: Escitalopram	0.67	± 1.15
Research Frequency Management: Escitalopram	1.50	± 1.31

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were monitored over a period of 8 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Clinical Frequency Management: Placebo

Serious: 0/5 (0%)

Deaths: 0/5

Research Frequency Management: Placebo

Serious: 0/7 (0%)

Deaths: 0/7

Clinical Frequency Management: Escitalopram

Serious: 0/5 (0%)

Deaths: 0/5

Research Frequency Management: Escitalopram

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	Clinical Frequency Managem…	Research Frequency Managem…	Clinical Frequency Managem…	Research Frequency Managem…
Dehydration	Surgical and medical procedures	—	—	—	—

Other adverse events (28 terms — click to expand)

Reaction	System	Clinical Frequency Managem…	Research Frequency Managem…	Clinical Frequency Managem…	Research Frequency Managem…
Diarrhea	Gastrointestinal disorders	—	—	—	—
Dry Mouth	General disorders	—	—	—	—
Body Pain	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Headache	General disorders	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Urinary Frequency/Urgency	Renal and urinary disorders	—	—	—	—
Anorexia	Psychiatric disorders	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—
Diaphoresis	General disorders	—	—	—	—
Dizziness	General disorders	—	—	—	—
Drowsiness	General disorders	—	—	—	—
Excitement	Psychiatric disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Insomnia	General disorders	—	—	—	—
Memory Loss	Psychiatric disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Orgasm Delay	Reproductive system and breast disorders	—	—	—	—
Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Suicidal Ideation	Psychiatric disorders	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—
Tremor	Nervous system disorders	—	—	—	—
Vivid Dreams	Psychiatric disorders	—	—	—	—
Weakness	General disorders	—	—	—	—
Weight Gain	General disorders	—	—	—	—

Most-reported serious reactions: Dehydration.

Data from ClinicalTrials.gov NCT03812588 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.