Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram
Condition: Depression
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate changes in brain energy metabolism due to treatment with
      escitalopram in people with major depressive disorder.
    

Detailed description: 
      Major depressive disorder (MDD) is a severe form of depression. MDD can significantly
      interfere with an individual's thoughts, behavior, mood, and physical health. People who
      suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be
      unable to cope with problems in their life. In addition, they often experience sleep
      disruption, loss of appetite, and chronic pain.

      Antidepressant medications are often prescribed for treating MDD; however, 30% to 40% of
      individuals fail to respond adequately to medication. Preliminary research has shown that
      lower levels of brain energy metabolism are often associated with MDD. No studies have yet
      shown whether there is a difference in brain energy metabolism between individuals who
      respond well to antidepressants versus those who do not. Escitalopram is an antidepressant
      medication often used to treat MDD. It causes a calming effect and reduces anxiety by
      increasing the amount of serotonin in the brain. This study will compare the changes in brain
      energy metabolism due to treatment with escitalopram in individuals with MDD. In turn, these
      findings may aid in understanding the relationship between brain energy metabolism and
      depression, and may guide future antidepressant trials.

      This 12-week study will enroll individuals diagnosed with MDD, as well as healthy
      individuals. During Weeks 1 through 4, participants with MDD will receive 10 mg of
      escitalopram on a daily basis. If a participant does not respond well to the medication, as
      determined by the study clinician, the dose may be increased to 20 mg per day for Weeks 5
      through 8. If a participant continues to not respond to the medication after 8 weeks, the
      dose may be increased to 30 mg per day for Weeks 9 through 12. Study visits will occur every
      other week throughout the 12 weeks. Laboratory tests, physical examinations, and vital sign
      measurements will be performed at each study visit. Outcome measurements will include
      depression levels as assessed by standardized psychological tests and questionnaires, as well
      as brain energy metabolite levels as assessed by magnetic resonance spectroscopy (MRS) and
      magnetic resonance imaging (MRI) scans. The MRS and MRI scans will occur at baseline, Week 2,
      and Week 12; the entire scanning procedure will last 70-80 minutes. Following the end of the
      study, all participants will be offered follow-up medical care for 3 months. Participants who
      responded well to escitalopram will be offered continued treatment with the drug, while those
      who did not respond well to escitalopram will be offered treatment with another
      antidepressant.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram 10 to 30 mg per day for 12 weeks
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain Bioenergetic Metabolism; Magnetic Resonance Spectroscopy; Major Depressive Disorder; Treatment Response