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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00610506
First received: January 28, 2008
Last updated: May 30, 2013
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Atypical Depression
Drug: Escitalopram
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study -- An Open-Label, Rater-blinded, Flexible-dose, 8-week Trial of Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • changes in HAM-D-29 scores from baseline to end of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Lexapro
Drug: Escitalopram
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.
Other Name: Escitalopram (Lexapro)

Detailed Description:

Based on treatment outcome, longitudinal course, biologic and physiologic data, and family histories (Rabkin et al., 1996), the American Psychiatric Association's Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) (American Psychiatric Association, 1994) added atypical features as a parenthetical modifier of major depression and dysthymia. Several recent reports suggest that DSM-IV criteria for depression with atypical features identify a group distinguishable by a cluster of symptoms, age of onset and course of illness. The symptom constellation consists of depressed mood, along with hyperphagia, weight gain, increased fatigue and rejection sensitivity. Some authors have distinguished two subtypes of atypical depression. One subtype has an early onset (i.e., before age 20 years) and a chronic course (i.e., no spontaneous well-being since onset greater than 2 months) (early/chronic atypical) are no more likely to benefit from tricyclic antidepressant than from placebo (Stewart et al., 2002), but do respond to a monoamine oxidase inhibitor, and do not have increased left hemisphere perceptual processing (Stewart et al., 2003). In contrast, the other subtype reports either later onset or a less chronic course of illness (late/nonchronic atypical) respond robustly to tricyclic antidepressant (Stewart et al., 2002), and show evidence of increased left hemispheric processing (Stewart et al., 2003).

The role of the newer medications in the treatment of depressed patients with atypical features remains to be elucidated. One study compared outcome between phenelzine and fluoxetine, reporting no difference, but risk of a type II error was large (Pande et al. 1996). A second study limited to depressed patients with atypical features compared fluoxetine, imipramine, and placebo, finding both drugs effective for about half the patients and both superior to placebo, but not different from each other (McGrath et al. 2000). A 12-week study comparing moclobemide and sertraline in the treatment of outpatients with atypical depression found both drugs to produce comparable improvement (Sogaard et al, 1999). Falkai (1999) asserts the efficacy of mirtazapine for depression with atypical features without any data, and Rye et al. (1998) reported on a single case of apparently late onset atypical depression responding to bupropion. A placebo controlled study failed to show any benefit for mianserin for atypical depression (McGrath et al, 1985). Finally, an unmarketed drug, gepirone, has been demonstrated to be effective for depression with atypical features but no comparison was made with other antidepressant medications (McGrath et al., 1994).

Escitalopram has been approved for the treatment of major depression and Generalized Anxiety Disorder. However whether escitalopram improved atypical depressive symptoms has not been investigated.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18 to 65 years,
  2. DSM-IV episode of Major Depression non-psychotic with atypical features.
  3. ≥19 score on the 29-item HAM-D,
  4. ability to give informed consent, if patients are of child-bearing potential
  5. A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine).

Exclusion Criteria:

  1. bipolar depression,
  2. Any Axis I psychotic disorder
  3. currently suicidal or suicide risk,
  4. history of substance abuse in the previous 12 months,
  5. history of hypersensitivity to escitalopram, or citalopram
  6. serious or unstable medical disorders,
  7. starting or terminating psychotherapy during the previous 12 weeks,
  8. ECT treatment in the previous 3 months,
  9. pregnancy or planning pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610506

Locations
United States, North Carolina
Dept Psychiatry, Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Forest Laboratories
Investigators
Principal Investigator: Aswin A Patkar, M.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00610506     History of Changes
Other Study ID Numbers: 7842, IRB#7842
Study First Received: January 28, 2008
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Atypical Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 14, 2014