SchizophreniaNCT00833547
Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
A study testing eszopiclone in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- eszopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2012
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia
Who cannot join
- History of neurologic or psychiatric disease other than schizophrenia
- Substance abuse or dependence within the past six months
- Other chronic medical conditions that affect sleep
- Pregnancy/breast feeding
- Hepatic impairment
- Treatment with metabolic inhibitors or inducers
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.
- Conditions
- Schizophrenia
- Being tested
- eszopiclone, placebo
- Keywords
- sleep, schizophrenia, procedural learning, motor skill
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eszopicloneDrug
Also called Lunesta
3 mg of eszopiclone at bedtime on two consecutive nights
placeboDrug
Placebo capsules looking identical to eszopiclone at bedtime on two consecutive nights
| Study group | Role | What they receive |
|---|---|---|
| Eszopiclone | Experimental | 3mg of eszopiclone on two consecutive nights Receives: Drug: eszopiclone |
| placebo | Placebo comparator | placebo capsule that looks identical to eszopiclone capsule on two consecutive nights Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight Change on Finger Tapping Task
The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
Measured: Train on Day 3 and Test on Day 4 of study (experimental nights)
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
2 baseline nights (Days 1 \&2); 2 experimental nights (Days 3 \&4)
Measured: during two nights in an inpatient Clinical Research Center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2012
- Study completionSep 2012
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 SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Dara S. Manoach, PhD, Massachusetts General Hospital
- Investigators
- Dara S. Manoach, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833547
- Sponsor's protocol ID
- Sepracor051
- Status last verified
- Aug 2014
- First submitted
- 29 Jan 2009
- Last updated
- 9 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
- ClinicalTrials.gov ID
- NCT00833547
- Acronym / sponsor ID
- Sepracor051
- Conditions
- Schizophrenia
- Keywords
- sleep, schizophrenia, procedural learning, motor skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc., Beth Israel Deaconess Medical Center
- Study start
- Sep 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 9 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. The investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eszopiclone | Experimental | Drug: eszopiclone3mg of eszopiclone on two consecutive nights |
| placebo | Placebo comparator | Drug: placeboplacebo capsule that looks identical to eszopiclone capsule on two consecutive nights |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia
Key exclusion criteria (6 listed)
- History of neurologic or psychiatric disease other than schizophrenia
- Substance abuse or dependence within the past six months
- Other chronic medical conditions that affect sleep
- Pregnancy/breast feeding
- Hepatic impairment
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: Lunesta3 mg of eszopiclone at bedtime on two consecutive nights | Drug | Eszopiclone |
| placeboPlacebo capsules looking identical to eszopiclone at bedtime on two consecutive nights | Drug | placebo |
Primary outcome
Overnight Change on Finger Tapping Task
Time frame: Train on Day 3 and Test on Day 4 of study (experimental nights)
The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) "as quickly and accurately as possible" for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning.
Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography
Time frame: during two nights in an inpatient Clinical Research Center
2 baseline nights (Days 1 \&2); 2 experimental nights (Days 3 \&4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- 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.
Dara S. Manoach, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eszopiclone in people with Schizophrenia, run by Massachusetts General Hospital 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 1 inclusion and 6 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 9 Sep 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2014). 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?
Overnight Change on Finger Tapping Task (time frame: Train on Day 3 and Test on Day 4 of study (experimental nights)). 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 9 Sep 2014.