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Completed

NCT Number: NCT00826111

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Steward St. Elizabeth's Medical Center of Boston, Inc.

Boston, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eszopiclone

Drug

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.

Other names: Lunesta

Placebo

Drug

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.

Primary outcomes

  1. Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.

    Time frame: baseline and 1 week

    Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

  2. Change in Thalamic Glutamine From Baseline to Week 1

    Time frame: baseline and 1 week

    Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

Secondary outcomes

  1. Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1

    Time frame: baseline and 1 week

    Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

  2. Change in Thalamic Glutamate From Baseline to Week 1

    Time frame: baseline and 1 week

    Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

  3. Change in Anterior Cingulate Cortex GABA From Baseline to Week 1

    Time frame: baseline and 1 week

    GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

  4. Change in Thalamic GABA From Baseline to Week 1

    Time frame: baseline and 1 week

    GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.

  5. Change in Hamilton Depression Rating Scale Score From Baseline to Week 10

    Time frame: baseline and 10 weeks

    The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms.

  6. Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10

    Time frame: baseline and 10 weeks

    The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study.

  7. Change in Insomnia Severity Index Score From Baseline to Week 10

    Time frame: baseline and 10 weeks

    The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.

Sponsors and collaborators

Lead sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Other

Collaborators

  • Sumitomo Pharma America, Inc.

Registry information

Official study title

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2009
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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