The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Condition: Depression; Anxiety; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder; Anxiety Disorders
Intervention: Eszopiclone; Placebo
Intervention description: Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone.; Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Magnetic Resonance Spectroscopy; Glutamate; Glutamine; GABA; Lexapro; Lunesta; Escitalopram; Eszopiclone

Summary:

      The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and
      levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression,
      anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate,
      glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis
      was that levels of glutamine and glutamate will be increased in women receiving eszopiclone
      compared to those receiving placebo. The antidepressant effect of the medication combination
      and its effect on sleep status was also assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female aged 18 to 55 years and regularly menstruating.

          -  Meets DSM-IV criteria for unipolar major depression.

          -  Insomnia severity index score > 10.

          -  Hamilton Anxiety scale score > 15.

          -  Hamilton Depression scale score > 17.

          -  Capable of providing informed consent.

          -  Has an established residence and phone.

        Exclusion Criteria:

          -  Meets DSM-IV criteria for schizophrenia, schizoaffective disorder or other axis I or
             II diagnosis except co-morbid anxiety disorder and insomnia.

          -  Actively abusing substances or alcohol; or has met DSM-IV criteria for substance
             dependence in the past month.

          -  Pregnancy.

          -  Use of benzodiazepines or other sedative-hypnotics, beta blockers, calcium channel
             blockers, antidepressants, antipsychotic medications, lithium or other medication
             which in the opinion of the investigator could alter glutamate or GABA activity in the
             brain.

          -  A medical condition, which in the opinion of the investigator could possibly affect
             the individual's brain levels of Glu and GABA.

          -  Participation in a research protocol that included administration of medication within
             the past 3 months.

          -  Cigarette smoking.

          -  Subject has known allergic sensitivity to any of the study to escitalopram,
             eszopiclone or zopiclone.

          -  Clinically significant suicidal ideation or risk of suicide as evidenced by
             formulation of a plan or steps taken to act on those feelings.

          -  History of clinically significant hepatic impairment.

          -  Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir,
             nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole,
             itraconazole) and is unwilling or it is clinically contraindicated to stop the
             medication.