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

NCT ID: NCT00826111

Last Updated: 2012-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-07-31

Brief 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.

Conditions

Depression; Anxiety; Insomnia

Keywords

Magnetic Resonance Spectroscopy; Glutamate; Glutamine; GABA; Lexapro; Lunesta; Escitalopram; Eszopiclone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Eszopiclone

Lexapro for 10 weeks together with eszopiclone.

Group Type: ACTIVE_COMPARATOR

Eszopiclone

Intervention Type: 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.

Placebo

Lexapro for 10 weeks together with placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Eszopiclone

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.

Intervention Type: DRUG

Placebo

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 Type: DRUG

Other Intervention Names

Lunesta

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael E Henry, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

00427

Identifier Type: -

Identifier Source: org_study_id