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Trial record 85 of 534 for:    ESCITALOPRAM AND Disorders

Neurobiological Bases of Placebo Response in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01787240
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : February 8, 2013
Results First Posted : April 14, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram 10mg
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Escitalopram 10mg
Hide Arm/Group Description

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Placebo

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg

Period Title: Overall Study
Started 15 5
Completed 10 4
Not Completed 5 1
Arm/Group Title Placebo Escitalopram 10mg Total
Hide Arm/Group Description

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Placebo

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg

Total of all reporting groups
Overall Number of Baseline Participants 15 5 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 5 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
5
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 5 participants 20 participants
32.6  (14.10) 33  (11.64) 32.7  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 5 participants 20 participants
Female
7
  46.7%
3
  60.0%
10
  50.0%
Male
8
  53.3%
2
  40.0%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 5 participants 20 participants
15 5 20
1.Primary Outcome
Title Feasibility
Hide Description We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).
Time Frame This would occur at the first study visit (screening).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eligible Patients
Hide Arm/Group Description:
Number of patients who were screened and were determined to be eligible for the study.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percent of eligible patients
95.2
2.Secondary Outcome
Title Effects of Acute Tryptophan Depletion on Mood
Hide Description

We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.

The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.

A negative change value refers to a decrease in HAM D score.

Time Frame Baseline, Visit 10 (after 9 weeks in study)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Arm/Group Title Phase 2 Placebo Phase 2 Active
Hide Arm/Group Description:
Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.0  (6.4) -13.0  (12.1)
3.Secondary Outcome
Title Effects of Acute Tryptophan Depletion on Mood
Hide Description

We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.

The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.

A negative change value refers to a decrease in HAM D score.

Time Frame Baseline, Visit 5 (4 weeks into study)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were randomized to take placebo or active drug
Arm/Group Title Placebo Escitalopram 10mg
Hide Arm/Group Description:

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Placebo

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg

Overall Number of Participants Analyzed 12 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.4  (8.5) -8.8  (6.3)
4.Other Pre-specified Outcome
Title Effects of Acute Tryptophan Depletion on Serotonin Binding
Hide Description

We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.

Data were not collected

Time Frame Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Placebo Escitalopram 10mg
Hide Arm/Group Description:

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Placebo

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Escitalopram 10mg
Hide Arm/Group Description

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Placebo

After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg

All-Cause Mortality
Placebo Escitalopram 10mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Escitalopram 10mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      2/5 (40.00%)    
Cardiac disorders     
Chest pain   1/15 (6.67%)  1 0/5 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus   1/15 (6.67%)  1 0/5 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   0/15 (0.00%)  0 1/5 (20.00%)  2
Dry mouth   1/15 (6.67%)  1 0/5 (0.00%)  0
Infections and infestations     
Upper respiratory infection   0/15 (0.00%)  0 1/5 (20.00%)  1
Pancreatitis/Influenza   1/15 (6.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Escitalopram 10mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/15 (80.00%)      1/5 (20.00%)    
Cardiac disorders     
Chest pain/pressure   1/15 (6.67%)  2 0/5 (0.00%)  0
Heart palpitations   1/15 (6.67%)  1 0/5 (0.00%)  0
Ear and labyrinth disorders     
Tinnitus   1/15 (6.67%)  1 0/5 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   2/15 (13.33%)  2 1/5 (20.00%)  2
Gas/irregular Bowels   1/15 (6.67%)  1 0/5 (0.00%)  0
Nausea   4/15 (26.67%)  4 0/5 (0.00%)  0
Constipation   2/15 (13.33%)  3 0/5 (0.00%)  0
Acid reflux   1/15 (6.67%)  1 0/5 (0.00%)  0
Bloated   1/15 (6.67%)  2 0/5 (0.00%)  0
General disorders     
Dry mouth   1/15 (6.67%)  1 0/5 (0.00%)  0
Infections and infestations     
Cold/sinus infection   1/15 (6.67%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis   1/15 (6.67%)  1 0/5 (0.00%)  0
Shoulder pain/numbness   1/15 (6.67%)  1 0/5 (0.00%)  0
Nervous system disorders     
Headache   3/15 (20.00%)  5 1/5 (20.00%)  2
Sleep paralysis   1/15 (6.67%)  1 0/5 (0.00%)  0
Insomnia   2/15 (13.33%)  2 0/5 (0.00%)  0
Dizziness   1/15 (6.67%)  1 0/5 (0.00%)  0
Fatigue   1/15 (6.67%)  2 0/5 (0.00%)  0
Psychiatric disorders     
Anxiety attack   3/15 (20.00%)  3 0/5 (0.00%)  0
Irritability   2/15 (13.33%)  2 0/5 (0.00%)  0
Memory issues   1/15 (6.67%)  1 0/5 (0.00%)  0
Emotional lability   1/15 (6.67%)  1 0/5 (0.00%)  0
Sexual Interest/Libido   1/15 (6.67%)  5 0/5 (0.00%)  0
Vascular disorders     
Hypotension   1/15 (6.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
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
Name/Title: Dr. Cristina Cusin
Organization: MGH
Phone: 617 726 6421
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01787240     History of Changes
Other Study ID Numbers: 2012P001241
First Submitted: January 16, 2013
First Posted: February 8, 2013
Results First Submitted: March 2, 2017
Results First Posted: April 14, 2017
Last Update Posted: May 16, 2017