DepressionPhase 4NCT00826111
The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
A Phase 4 study testing Eszopiclone in people with Depression and Anxiety, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Depression, Anxiety, Insomnia
- What is being tested?
- Eszopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston, Massachusetts, 02135
About this study
Official title: The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study
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
- Being tested
- Eszopiclone, Placebo
- Keywords
- Magnetic Resonance Spectroscopy, Glutamate, Glutamine, GABA, Lexapro, Lunesta, Escitalopram, Eszopiclone
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Also called Lunesta
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Active comparator | Lexapro for 10 weeks together with eszopiclone. Receives: Drug: Eszopiclone |
| Placebo | Placebo comparator | Lexapro for 10 weeks together with placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.
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.
Measured: baseline and 1 week
Change in Thalamic Glutamine From Baseline to Week 1
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.
Measured: baseline and 1 week
Secondary outcomes (7)
Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1
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.
Measured: baseline and 1 week
Change in Thalamic Glutamate From Baseline to Week 1
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.
Measured: baseline and 1 week
Change in Anterior Cingulate Cortex GABA From Baseline to Week 1
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.
Measured: baseline and 1 week
Change in Thalamic GABA From Baseline to Week 1
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.
Measured: baseline and 1 week
Change in Hamilton Depression Rating Scale Score From Baseline to Week 10
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.
Measured: baseline and 10 weeks
Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10
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.
Measured: baseline and 10 weeks
Change in Insomnia Severity Index Score From Baseline to Week 10
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.
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael E Henry, MD, Principal investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826111
- Sponsor's protocol ID
- 00427
- Status last verified
- Jun 2012
- First submitted
- 19 Jan 2009
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Co-morbid Anxiety and Insomnia: A Proton MRS Study
- ClinicalTrials.gov ID
- NCT00826111
- Acronym / sponsor ID
- 00427
- Conditions
- Depression, Anxiety, Insomnia
- Keywords
- Magnetic Resonance Spectroscopy, Glutamate, Glutamine, GABA, Lexapro, Lunesta, Escitalopram, Eszopiclone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 29 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Active comparator | Drug: EszopicloneLexapro for 10 weeks together with eszopiclone. |
| Placebo | Placebo comparator | Drug: PlaceboLexapro for 10 weeks together with placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EszopicloneAlso: LunestaSubjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone. | Drug | Eszopiclone |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
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.
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.
7 secondary outcomes
Change in Anterior Cingulate Cortex Glutamate 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
Change in Anterior Cingulate Cortex GABA From Baseline to Week 1
Time frame: baseline and 1 week
Change in Thalamic GABA From Baseline to Week 1
Time frame: baseline and 1 week
Change in Hamilton Depression Rating Scale Score From Baseline to Week 10
Time frame: baseline and 10 weeks
Change in Hamilton Anxiety 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Henry, MD principal investigator
Steward St. Elizabeth's Medical Center of Boston, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eszopiclone in people with Depression and Anxiety, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1. (time frame: baseline and 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.