Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features
Condition: Atypical Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Escitalopram (Lexapro)
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atypical Depression