Biological Markers of Response to Treatment in Major Depressive Disorder

NCT00361218 | Completed Phase 3 Results DMC

• 1 other identifier: 2005P000413
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).

Conditions

Major Depressive Disorder

Keywords

depression; biology

Outcome Measures

Primary Outcomes (2)

• Serum Brain-derived Neurotrophic Factor (BDNF) Levels

  "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.

  8 weeks

• Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response

  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).

  8 weeks

Study Arms (1)

open-label selective serotonin reuptake inhibitor (SSRI)

OTHER

citalopram or escitalopram

Drug: open-label selective serotonin reuptake inhibitor (SSRI)

Interventions

open-label selective serotonin reuptake inhibitor (SSRI) DRUG

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.

Also known as: escitalopram or citalopram

open-label selective serotonin reuptake inhibitor (SSRI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65
• Meet criteria for current Major Depressive Disorder
• Antidepressant medication-free for at least 2 weeks prior to the start of the study

You may not qualify if:

• Pregnant or breastfeeding women
• Anyone who is suicidal
• Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania
• Anyone currently taking an SSRI
• Past intolerance to Lexapro or Celexa

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram; Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: John W. Denninger, MD, PhD
• Organization: Massachusetts General Hospital

jdenninger@partners.org

617-726-2985

Study Officials

• John Denninger, MD, PhD

  Depression Clinical and Research Program, Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychiatry

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 8, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 11, 2018
• Results First Posted: September 26, 2013

Record last verified: 2018-04