Major Depressive DisorderPhase 2NCT01189318
Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder
A Phase 2 study testing Quetiapine Fumarate Extended Release in people with Major Depressive Disorder, run by Ewha Womans University at 1 site in South Korea.
Trial summary
In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Quetiapine Fumarate Extended Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Feb 2014
- Phase
- Phase 2
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)
- Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization
- Drug abuse in past 3 months
- Women who are pregnant，breastfeeding, or planning pregnancy
- Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
- Unstable medical illness or severe abnormality in laboratory test at screening assessment
Show all 21Show fewer
- Increase in blood glucose, lipid, and calcium levels at screening
- Low blood pressure at screening assessment
- Intelligence quotient below 80
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 3 months prior to enrolment
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- A patient with Diabetes Mellitus
- An absolute neutrophil count (ANC) of <= 1.5 x 10^9 per liter
- Insomnia from other causes of medical or neurological diseases
- Involvement in the planning and conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder
In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.
- Conditions
- Major Depressive Disorder
- Being tested
- Quetiapine Fumarate Extended Release
- 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.
Quetiapine Fumarate Extended ReleaseDrug
Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed)
| Study group | Role | What they receive |
|---|---|---|
| Seroquel XR | Experimental | Patients with MDD receives Seroquel XR. Receives: Drug: Quetiapine Fumarate Extended Release |
| healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Pittsburgh Quality Index total scores at 4 weeks
Measured: baseline and 4 weeks
change from baseline Pittsburgh Quality Index total scores at 2 weeks
Measured: baseline and 2 weeks
change from baseline Pittsburgh Quality Index total scores at 4 days
Measured: baseline and 4 days
Secondary outcomes (4)
change from baseline in sleep architecture measured using polysomnography at 4 weeks
Measured: baseline and at 4 weeks
number of participants with adverse events
Measured: 4 weeks
number of participants with adverse events
Measured: 2 weeks
number of participants with adverse events
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- Inkyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189318
- Sponsor's protocol ID
- D1443C00042
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01189318
- Acronym / sponsor ID
- D1443C00042
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Aug 2010 (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.
In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seroquel XR | Experimental | Drug: Quetiapine Fumarate Extended ReleasePatients with MDD receives Seroquel XR. |
| healthy control | No intervention | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)
- Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization
- Drug abuse in past 3 months
- Women who are pregnant，breastfeeding, or planning pregnancy
- Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
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 |
|---|---|---|
| Quetiapine Fumarate Extended ReleaseDay 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed) | Drug | Seroquel XR |
Primary outcome
change from baseline Pittsburgh Quality Index total scores at 4 weeks
Time frame: baseline and 4 weeks
change from baseline Pittsburgh Quality Index total scores at 2 weeks
Time frame: baseline and 2 weeks
change from baseline Pittsburgh Quality Index total scores at 4 days
Time frame: baseline and 4 days
4 secondary outcomes
change from baseline in sleep architecture measured using polysomnography at 4 weeks
Time frame: baseline and at 4 weeks
number of participants with adverse events
Time frame: 4 weeks
number of participants with adverse events
Time frame: 2 weeks
number of participants with adverse events
Time frame: 4 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Inkyoon Lyoo, MD, PhD, MMS principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quetiapine Fumarate Extended Release in people with Major Depressive Disorder, run by Ewha Womans University at 1 site in South Korea.
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 0 inclusion and 21 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: withdrawn, as of the sponsor's last update on 7 Aug 2015. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from baseline Pittsburgh Quality Index total scores at 4 weeks (time frame: baseline and 4 weeks). The study lists 3 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 7 Aug 2015.