Bipolar DisorderPhase 4NCT00520507
An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
A Phase 4 study testing Olanzapine in people with Bipolar Disorder and Depression, run by Queen's University at 1 site in Canada.
Trial summary
OBJECTIVES: Primary Objective: To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Depression, Depressive Disorder
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to May 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of major depressive disorder or bipolar disorder type 1, 2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Current depressive episode with a HAMD-17 of > 15
- Males or females over age18 years (yrs)
- Inpatients or outpatients
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
- Able to understand and comply with the requirements of the study
- Provision of written informed consent
Who cannot join
- Current manic, hypomanic or mixed episode, with YMRS > 12
- Current or past diagnosis of schizophrenia and dementia
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
- Patient on any other 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 olanzapine, as judged by the investigator
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- Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study
- No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading
- Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization
- Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Serious, unstable or inadequately treated medical illness as judged by the investigator
- History of epilepsy or uncontrolled seizures
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University, Providence Care-Mental Health Services
Kingston, Ontario, K7L 4X3
About this study
OBJECTIVES:
Primary Objective:
Read more
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression.
Secondary Objectives:
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of olanzapine in treatment, longitudinally, and to correlate these changes with measures of illness severity and changes in cognition.
STUDY DESIGN:
Prospective, double blind, randomized polysomnographic (PSG) study of patients before and after treatment with olanzapine.
PSG recordings will be done three times throughout the study: before starting olanzapine augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep quality scales, and cognition measurements will be completed at each visit.
- Conditions
- Bipolar Disorder, Depression, Depressive Disorder
- Being tested
- Olanzapine, Placebo
- Keywords
- Depression, Bipolar Disorder, Major
- Medical subject headings
- Bipolar Disorder, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Olanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated.
PlaceboDrug
An inactive form of the treatment will be taken once daily at 6pm for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Olanzapine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
Measured: 3 days after baseline and 1 month after baseline
Secondary outcomes (6)
Sleep measures: time in bed, total sleep time, sleep period time, percentage of sleep stages (stage 1, stage 2, slow wave sleep, REM sleep) of sleep period time, sleep latency to stage 1 and 2, REM latency, number of awakenings.
Measured: measure taken at baseline, 3 days after baseline, and 1 month after baseline
Respiratory events (during PSG): obstructive sleep apneas, mixed apneas, central apneas, total apneas, obstructive hypopneas, mixed hypopneas, central hypopneas, total hypopneas, and apneas + hypopneas (AHI), oxygen saturation, and heart rate.
Measured: Baseline, 3 days and 1 month after baseline
Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.
Measured: Baseline, 3 days and 1 month after baseline
Changes in weight and blood glucose will be monitored.
Measured: At baseline and 1 month
Cognition: CANTAB scores
Measured: Baseline, 3 days and 1 month after baseline
Illness severity: HDRS-17, MADRS, CGI and HamA
Measured: Baseline, 3 days and 1 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen Milev, M.D., Principal investigator, Queen's University, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520507
- Sponsor's protocol ID
- PSIY-263-07
- Status last verified
- Dec 2015
- First submitted
- 22 Aug 2007
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lazowski LK, Townsend B, Hawken ER, Jokic R, du Toit R, Milev R. Sleep architecture and cognitive changes in olanzapine-treated patients with depression: a double blind randomized placebo controlled trial. BMC Psychiatry. 2014 Jul 17;14:202. doi: 10.1186/1471-244X-14-202.
PubMed 25030264
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
- An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients
- ClinicalTrials.gov ID
- NCT00520507
- Acronym / sponsor ID
- PSIY-263-07
- Conditions
- Bipolar Disorder, Depression, Depressive Disorder
- Keywords
- Depression, Bipolar Disorder, Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Aug 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.
OBJECTIVES:
Primary Objective:
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of olanzapine in treatment of patients with depression.
Secondary Objectives:
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of olanzapine in treatment, longitudinally, and to correlate these changes with measures of illness severity and changes in cognition.
STUDY DESIGN:
Prospective, double blind, randomized polysomnographic (PSG) study of patients before and after treatment with olanzapine.
PSG recordings will be done three times throughout the study: before starting olanzapine augmentation (baseline), at day 3 to 5 (acute) and day 28 to 31 (chronic). PSG will be completed at patients' homes with a portable PSG. Psychiatric scales, subjective sleep quality scales, and cognition measurements will be completed at each visit.
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 |
|---|---|---|
| 1 | Experimental | Drug: Olanzapine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of major depressive disorder or bipolar disorder type 1, 2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Current depressive episode with a HAMD-17 of > 15
- Males or females over age18 years (yrs)
- Inpatients or outpatients
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
Key exclusion criteria (15 listed)
- Current manic, hypomanic or mixed episode, with YMRS > 12
- Current or past diagnosis of schizophrenia and dementia
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
- Patient on any other 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 |
|---|---|---|
| OlanzapineOlanzapine will be taken once daily at 6pm for 1 month. Dosing will be titrated up to 5mg and then changed as clinically indicated. | Drug | 1 |
| PlaceboAn inactive form of the treatment will be taken once daily at 6pm for 1 month. | Drug | 2 |
Primary outcome
Sleep quality as measured by overnight PSG, defined as the change in time spent in slow wave sleep.
Time frame: 3 days after baseline and 1 month after baseline
6 secondary outcomes
Sleep measures: time in bed, total sleep time, sleep period time, percentage of sleep stages (stage 1, stage 2, slow wave sleep, REM sleep) of sleep period time, sleep latency to stage 1 and 2, REM latency, number of awakenings.
Time frame: measure taken at baseline, 3 days after baseline, and 1 month after baseline
Respiratory events (during PSG): obstructive sleep apneas, mixed apneas, central apneas, total apneas, obstructive hypopneas, mixed hypopneas, central hypopneas, total hypopneas, and apneas + hypopneas (AHI), oxygen saturation, and heart rate.
Time frame: Baseline, 3 days and 1 month after baseline
Subjective sleep experience: visual analogue scale, sleep diary, Epworth Sleep Scale and Pittsburgh Sleep Quality Index.
Time frame: Baseline, 3 days and 1 month after baseline
Changes in weight and blood glucose will be monitored.
Time frame: At baseline and 1 month
Cognition: CANTAB scores
Time frame: Baseline, 3 days and 1 month after baseline
Illness severity: HDRS-17, MADRS, CGI and HamA
Time frame: Baseline, 3 days and 1 month after baseline
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.
- Derived from this study: PubMed 25030264Lazowski LK, Townsend B, Hawken ER, Jokic R, du Toit R, Milev R. Sleep architecture and cognitive changes in olanzapine-treated patients with depression: a double blind randomized placebo controlled trial. BMC Psychiatry. 2014 Jul 17;14:202. doi: 10.1186/1471-244X-14-202.
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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 Milev, M.D. principal investigator
Queen's University, 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 Olanzapine in people with Bipolar Disorder and Depression, 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 7 inclusion and 15 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. 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?
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, defined as the change in time spent in slow wave sleep. (time frame: 3 days after baseline and 1 month after baseline). 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 NCT00520507, which also lists 1 linked publication.
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.