Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features

NCT00610506 | Completed Phase 3

• 2 other identifiers: 7842IRB#7842
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Aims of Study: The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features. Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.

Conditions

Atypical Depression

Keywords

Atypical Depression

Outcome Measures

Primary Outcomes (1)

• changes in HAM-D-29 scores from baseline to end of treatment.

  8 weeks

Secondary Outcomes (1)

• changes in 8-atypical items on the HAM-D-29, SDS and ESQ from baseline to end of treatment. Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.

  8 weeks

Study Arms (1)

A

EXPERIMENTAL

Lexapro

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability.

Also known as: Escitalopram (Lexapro)

A

Eligibility Criteria

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

You may qualify if:

• age 18 to 65 years,
• DSM-IV episode of Major Depression non-psychotic with atypical features.
• ≥19 score on the 29-item HAM-D,
• ability to give informed consent, if patients are of child-bearing potential
• A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine).

You may not qualify if:

• bipolar depression,
• Any Axis I psychotic disorder
• currently suicidal or suicide risk,
• history of substance abuse in the previous 12 months,
• history of hypersensitivity to escitalopram, or citalopram
• serious or unstable medical disorders,
• starting or terminating psychotherapy during the previous 12 weeks,
• ECT treatment in the previous 3 months,
• pregnancy or planning pregnancy.

Sponsors & Collaborators

• Duke University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Dept Psychiatry, Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Pae CU, Masand PS, Peindl K, Mannelli P, Han C, Marks DM, Patkar AA. An open-label, rater-blinded, flexible-dose, 8-week trial of escitalopram in patients with major depressive disorder with atypical features. Prim Care Companion J Clin Psychiatry. 2008;10(3):205-10. doi: 10.4088/pcc.v10n0305.

  PMID: 18615172 DERIVED

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aswin A Patkar, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: October 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 31, 2013

Record last verified: 2008-01

Locations

US (1)