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Trial record 85 of 210 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Escitalopram

Biological Markers of Response to Treatment in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00361218
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : September 26, 2013
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: open-label selective serotonin reuptake inhibitor (SSRI)
Enrollment 72
Recruitment Details Subjects were recruited from Boston/Salem Metropolitan Area via advertising on newspapers, television and radio, referrals from other clinicians, and patients who came into the Depression Research Program to participate in other studies
Pre-assignment Details After consenting to participate, subjects were screened for the study and, if found to be eligible, returned for their baseline visit after one week, during which no psychotropic medication was allowed.
Arm/Group Title Open-label Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description

citalopram or escitalopram

open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

Period Title: Overall Study
Started 53 [1]
Completed Baseline Assessment 47
Completed 30
Not Completed 23
Reason Not Completed
Lost to Follow-up             11
Personal Reasons             7
terminated / withdrawn due to toxicity /             5
[1]
met eligibility criteria and enrolled in the study
Arm/Group Title Open-label SSRI
Hide Arm/Group Description

citalopram or escitalopram

open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
  97.9%
>=65 years
1
   2.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
43.3  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
25
  53.2%
Male
22
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants
47
1.Primary Outcome
Title Serum Brain-derived Neurotrophic Factor (BDNF) Levels
Hide Description "Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:

citalopram or escitalopram

open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: pg/mL
Pre-SSRI BDNF Level 6077.270  (4371.67)
Post-SSRI BDNF Level 4393.24  (3263.70)
2.Primary Outcome
Title Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
Hide Description

Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation.

Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
QEEG data were collected, analyzed and reported as part of a larger trial. The analysis of QEEG data per protocol was only possible using the proprietary algorithm developed by a company; acquisition of that company precludes analysis for this study alone. Larger study reported in: Iosifescu DV et al. Eur Neuropsychopharmacol. 2009;19:772-7.
Arm/Group Title Open-label Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:

citalopram or escitalopram

open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label SSRI
Hide Arm/Group Description

citalopram or escitalopram

open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.

All-Cause Mortality
Open-label SSRI
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-label SSRI
Affected / at Risk (%) # Events
Total   0/47 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open-label SSRI
Affected / at Risk (%) # Events
Total   5/47 (10.64%)    
Gastrointestinal disorders   
nausea   1/47 (2.13%)  1
Metabolism and nutrition disorders   
weight gain   1/47 (2.13%)  1
lack of appetite   1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders   
increase in tremors   1/47 (2.13%)  1
Psychiatric disorders   
hypomania   1/47 (2.13%)  1
Indicates events were collected by systematic assessment
For the secondary outcome measure, the data were analyzed and reported as part of a larger trial; however, because the analysis could only be done using a proprietary algorithm, the subset for this study could not be independently analyzed.
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: John W. Denninger, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-726-2985
EMail: jdenninger@partners.org
Layout table for additonal information
Responsible Party: John W. Denninger, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361218     History of Changes
Other Study ID Numbers: 2005P000413
First Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: July 24, 2013
Results First Posted: September 26, 2013
Last Update Posted: May 11, 2018