Major Depressive DisorderPhase 4NCT00442481
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
A Phase 4 study testing Escitalopram and A baseline overnight polysomnography (oPSG) in people with Major Depressive Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design. Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram and A baseline overnight polysomnography (oPSG)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from MDD, excluding a depressive episode of Bipolar Disorder.
- The depressive episode is not secondary to a general medical condition or substance abuse.
- Ages between 18-65 years old.
- Patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
- Able to understand and sign an informed consent form.
Who cannot join
- Patients suffering from sleep disturbances due to a physical condition (COPD, sleep apnea or essential insomnia preceding the diagnosis of depression).
- Patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
- Patients suffering from a malignancy or neuro-degenerative such as Parkinsons' disease
- Patients suffering from a clinically significant psychiatric psychotic disease, as judged by DSM-IV criteria, such as schizophrenia or acute psychosis.
- Patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
- History of drug or alcohol dependence within the last year.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center, Department of psychiatry
Tel HaShomer
About this study
The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
Read the detailed description
Disturbance of sleep is a prominent symptom in depressive disorders. Alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. Polysomnographic recordings have confirmed these reports, reporting reduced latency of the first REM episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of REM sleep, a reduction of deep slow wave sleep (SWS) and increase in night awakenings (Benca et al., Classification of sleep disorders).
The effects of antidepressant drugs on depression and sleep disorders, specifically SSRIs, have been thoroughly researched. The effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis:
Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, A baseline overnight polysomnography (oPSG)
- Keywords
- MDD, Escitalopram, Cipralex, Sleep, REM, SWS, Polysomnography
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
A baseline overnight polysomnography (oPSG)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in latency of the first REM episode of the night.
Secondary outcomes (4)
Density of rapid eye movements
Changes of total percentage of REM sleep
Changes in deep slow wave sleep (SWS)
Number of night awakenings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Lundbeck Israel
- Investigators
- Jordan Lewinski, Dr., Principal investigator, Sheba Medical Center, Department of psychiatryMark Weiser, Dr., Study chair, Sheba Medical Center, Department of psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442481
- Sponsor's protocol ID
- SHEBA-06-4205-JL-CTIL
- Status last verified
- Mar 2007
- First submitted
- 1 Mar 2007
- Last updated
- 2 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. doi: 10.1001/archpsyc.1992.01820080059010.
PubMed 1386215Lader M, Andersen HF, Baekdal T. The effect of escitalopram on sleep problems in depressed patients. Hum Psychopharmacol. 2005 Jul;20(5):349-54. doi: 10.1002/hup.694.
PubMed 15912558
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00442481
- Acronym / sponsor ID
- SHEBA-06-4205-JL-CTIL
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Escitalopram, Cipralex, Sleep, REM, SWS, Polysomnography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Lundbeck Israel
- Study start
- Feb 2007
- First posted
- 2 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis: Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
Detailed description
Disturbance of sleep is a prominent symptom in depressive disorders. Alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. Polysomnographic recordings have confirmed these reports, reporting reduced latency of the first REM episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of REM sleep, a reduction of deep slow wave sleep (SWS) and increase in night awakenings (Benca et al., Classification of sleep disorders).
The effects of antidepressant drugs on depression and sleep disorders, specifically SSRIs, have been thoroughly researched. The effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design.
Hypothesis:
Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from MDD, excluding a depressive episode of Bipolar Disorder.
- The depressive episode is not secondary to a general medical condition or substance abuse.
- Ages between 18-65 years old.
- Patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
- Able to understand and sign an informed consent form.
Key exclusion criteria (6 listed)
- Patients suffering from sleep disturbances due to a physical condition (COPD, sleep apnea or essential insomnia preceding the diagnosis of depression).
- Patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
- Patients suffering from a malignancy or neuro-degenerative such as Parkinsons' disease
- Patients suffering from a clinically significant psychiatric psychotic disease, as judged by DSM-IV criteria, such as schizophrenia or acute psychosis.
- Patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
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 |
|---|---|---|
| Escitalopram | Drug | – |
| A baseline overnight polysomnography (oPSG) | Procedure or surgery | – |
Primary outcome
Change in latency of the first REM episode of the night.
4 secondary outcomes
Density of rapid eye movements
Changes of total percentage of REM sleep
Changes in deep slow wave sleep (SWS)
Number of night awakenings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
- Background: PubMed 1386215Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. doi: 10.1001/archpsyc.1992.01820080059010.
- Background: PubMed 15912558Lader M, Andersen HF, Baekdal T. The effect of escitalopram on sleep problems in depressed patients. Hum Psychopharmacol. 2005 Jul;20(5):349-54. doi: 10.1002/hup.694.
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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.
Jordan Lewinski, Dr. principal investigator
Sheba Medical Center, Department of psychiatry
Mark Weiser, Dr. study chair
Sheba Medical Center, Department of psychiatry
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 Escitalopram and A baseline overnight polysomnography (oPSG) in people with Major Depressive Disorder, run by Sheba Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Mar 2007. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Lewinski, Dr. (03-5303765, jordan@extopia.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in latency of the first REM episode of the night.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00442481, which also lists 2 linked publications.
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 2 Mar 2007.