Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Cognitive Behavioral Therapy (CBT); Escitalopram
Intervention description: The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.; The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder (MDD); Cognitive Behavioral Therapy (CBT); Escitalopram; Quantitative EEG (QEEG)

Summary:

      The purpose of this research study is to find out if a test can predict whether someone with
      depression will get better with treatment. We also want to find out whether there are changes
      in the brains of depressed patients having different types of treatment (drug therapy vs.
      talk therapy). We hope that a test called QEEG (Quantitative Electroencephalogram) can tell
      us if a treatment is going to work, even before the person starts to feel better.

      Hypothesis 1: Response to treatment will correlate with changes in QEEG metrics.

      Hypothesis 2: QEEG parameters, different from those that predict response to pharmacotherapy,
      will be associated with response to CBT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be adults, ages 18 to 75 years.

          -  Written informed consent

          -  MDD, current according to the fourth version of the Diagnostic and Statistical Manual
             for Mental Disorders (DSM-IV)

          -  17-item Hamilton Depression Rating Scale (HAM-D-17) score of > 14 at baseline.

          -  Subjects who are not currently taking any antidepressant or other psychotropic
             medications and who have been free of these medications for 4 weeks prior to screening
             visit.

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning a pregnancy during the study.

          -  Women of child bearing potential who are not using a medically accepted means of
             contraception (to include oral contraceptive or implant, condom, diaphragm,
             spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).

          -  Any uncontrolled psychiatric disorder.

          -  Current use of psychotropic medications.

          -  Psychotic features in the current episode or a history of psychotic features.

          -  Alcohol or substance abuse or dependence within the past three months.

          -  History of head trauma or seizure disorder.

          -  History of intolerance of the study medication.

          -  Failure to respond to escitalopram up to 20 mg for at least 6 weeks.

          -  Failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a
             therapeutic dose, equivalent to fluoxetine 40mg) in the current episode.

          -  Currently enrolled in other depression-focused psychotherapy and unwilling to cease
             treatment.

          -  Subjects who, per clinical judgment, are not appropriate candidates for CBT or SSRIs.

          -  History or current diagnosis of the following DSM-IV psychiatric illness: organic
             mental disorder, schizophrenia, schizoaffective disorder, delusional disorder,
             psychotic disorders not otherwise specified, bipolar disorder, patients with mood
             congruent or mood incongruent psychotic features, patients with substance dependence
             disorders, including alcohol, active within the last 3 months.

          -  Serious suicide or homicide risk, as assessed by the evaluating clinician or a score
             of 4 on the third item of the HAM-D.

          -  Serious or unstable medical illness, including cardiovascular, hepatic, renal,
             respiratory, endocrine, neurologic or hematologic disease