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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00826111
• Date of registration: 19/01/2009
• Primary sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Public title: The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
• Scientific title: The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study
• Date of first enrolment: August 2007
• Target sample size: 19
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00826111
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael E Henry, MD
• Affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Anxiety

Depression

Insomnia

Intervention(s)

Drug: Eszopiclone

Drug: Placebo

Primary Outcome(s)

Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1. [Time Frame: baseline and 1 week]

Change in Thalamic Glutamine From Baseline to Week 1 [Time Frame: baseline and 1 week]

Secondary Outcome(s)

Change in Anterior Cingulate Cortex GABA From Baseline to Week 1 [Time Frame: baseline and 1 week]

Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1 [Time Frame: baseline and 1 week]

Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10 [Time Frame: baseline and 10 weeks]

Change in Hamilton Depression Rating Scale Score From Baseline to Week 10 [Time Frame: baseline and 10 weeks]

Change in Insomnia Severity Index Score From Baseline to Week 10 [Time Frame: baseline and 10 weeks]

Change in Thalamic GABA From Baseline to Week 1 [Time Frame: baseline and 1 week]

Change in Thalamic Glutamate From Baseline to Week 1 [Time Frame: baseline and 1 week]

Secondary ID(s)

00427

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sunovion