Bipolar DisorderNCT00616889
Effect of Quetiapine on Sleep Architecture in Bipolar Depression and Major Depressive Disorder
An observational study of Bipolar Disorder, run by Queen's University at 1 site in Canada.
Trial summary
Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects may play an important role in restoring quality of sleep in patients with various psychiatric conditions who frequently experience sleep disturbances as part of their illness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Seroquel
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Jan 2009
- Phase
- Observational
- 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
Study population: Adults with current Major Depressive Disorder or Bipolar Depression
Who may be able to join
- Provision of written informed consent;
- A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV);OR Major Depressive Disorder
- Males or Females aged 18 years or more;
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment;
- Able to understand and comply with the requirements of the study;
- Current depressive episode with a HAM-D17 score of 15 or more.
Who cannot join
- Current Manic, Hypomanic or Mixed episode, with YMRS 12 or more;
- Current or past diagnosis of Schizophrenia;
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing;
- Patient on antipsychotic medication;
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others;
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator;
Show all 19Show fewer
- 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 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 randomization;
- 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 dependence by DSM-IV criteria within 4 weeks prior to enrolment;
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment;
- Unstable or inadequately treated medical illness (e.g., diabetes, angina pectoris, hypertension) as judged by the investigator;
- Involvement in the planning and conduct of the study;
- Previous enrolment in the present study;
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements;
- If participant's liver function testing is rated 2 in the upper limits of normal.
- Diagnosis of Dementia
- Regular use of benzodiazepines unless at a stable dose for at least 12 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study
Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects may play an important role in restoring quality of sleep in patients with various psychiatric conditions who frequently experience sleep disturbances as part of their illness. It is well known that depressive disorders are very frequently associated with significant sleep disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture contributes to its antidepressant properties.
Read the detailed description
Primary Objective:
To assess the objective (polysomnographic) change in sleep quality before and after introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or Major Depressive Disorder.
Secondary Objectives:
To assess the objective (polysomnographic) and subjective changes in sleep quality parameters before and at different stages after introduction of Seroquel (Quetiapine) treatment, longitudinally, and to correlate these changes with measures of illness severity.
Study Design:
Prospective polysomnographic (PSG) study of patients before and after treatment with Seroquel (Quetiapine). PSG recordings will be done three (optional four) times during the study: before starting the Seroquel (Quetiapine) (baseline), at day 2 to 4 (early) and day 21 to 28 (longer term). (Optional fourth PSG can be done at day 42-56). PSG will be completed at patients home with a portable PSG.
- Conditions
- Bipolar Disorder
- Being tested
- Seroquel
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroquelDrug
Also called Quetiapine
The dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Seroquel added to medication regime and sleep quality measured Receives: Drug: Seroquel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality as measured by overnight PSG.
Measured: baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen V Milev, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616889
- Sponsor's protocol ID
- PSIY-206-05
- Other IDs
- D1449C00011
- Status last verified
- Dec 2015
- First submitted
- 9 Sep 2005
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study
- ClinicalTrials.gov ID
- NCT00616889
- Acronym / sponsor ID
- PSIY-206-05
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Feb 2008 (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.
Clinical practice indicates that Quetiapine has sedating properties, and its sedative effects may play an important role in restoring quality of sleep in patients with various psychiatric conditions who frequently experience sleep disturbances as part of their illness. It is well known that depressive disorders are very frequently associated with significant sleep disturbance. Sleep disruption is a feature of Bipolar Disorder during both Depressed and Manic/Hypomanic episodes. Considering that Seroquel has good antidepressant properties (Calabrese, 2004), the investigators suggest that Seroquel's effect on sleep architecture contributes to its antidepressant properties.
Detailed description
Primary Objective:
To assess the objective (polysomnographic) change in sleep quality before and after introduction of Seroquel (Quetiapine) in treatment of patients with Bipolar Depression or Major Depressive Disorder.
Secondary Objectives:
To assess the objective (polysomnographic) and subjective changes in sleep quality parameters before and at different stages after introduction of Seroquel (Quetiapine) treatment, longitudinally, and to correlate these changes with measures of illness severity.
Study Design:
Prospective polysomnographic (PSG) study of patients before and after treatment with Seroquel (Quetiapine). PSG recordings will be done three (optional four) times during the study: before starting the Seroquel (Quetiapine) (baseline), at day 2 to 4 (early) and day 21 to 28 (longer term). (Optional fourth PSG can be done at day 42-56). PSG will be completed at patients home with a portable PSG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: SeroquelSeroquel added to medication regime and sleep quality measured |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with current Major Depressive Disorder or Bipolar Depression
Key inclusion criteria (6 listed)
- Provision of written informed consent;
- A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV);OR Major Depressive Disorder
- Males or Females aged 18 years or more;
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment;
- Able to understand and comply with the requirements of the study;
Key exclusion criteria (19 listed)
- Current Manic, Hypomanic or Mixed episode, with YMRS 12 or more;
- Current or past diagnosis of Schizophrenia;
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing;
- Patient on antipsychotic medication;
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others;
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 |
|---|---|---|
| SeroquelAlso: QuetiapineThe dosage is flexible from 50-600 mg based on the investigator's clinical judgement and patient tolerance. It may be raised or lowered at will. | Drug | 1 |
Primary outcome
Sleep quality as measured by overnight PSG.
Time frame: baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
Roumen V Milev, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Queen's University at 1 site in Canada.
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 6 inclusion and 19 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 16 Dec 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep quality as measured by overnight PSG. (time frame: baseline, day 2 to 4 (early) and day 21 to 28 (longer term). Optional reading at day 42-56). 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 16 Dec 2015.