Bipolar DisorderPhase 3NCT00277667
Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
A Phase 3 study testing Quetiapine in people with Bipolar Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Quetiapine
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2007
- Phase
- Phase 3
- 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
- Subjects must be 18 years of age or older.
- Subjects must have bipolar I, II, or not otherwise specified (NOS) disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. Of note, bipolar NOS disorder will include subjects with either recurrent or sporadic brief hypomanias (hypomanias of 1 to 3 days in duration).
- Subjects must have moderate-to-severe hypomanic symptoms or mild manic symptoms that must be clinically significant (at least mild) but no worse than moderately severe, defined as a CGI-BP scale for mania > 3 and < 5, on at least 2 assessment days at least 3 days apart during the screening phase.
- Subjects must not be receiving mood stabilizing, antidepressant, or antipsychotic medication for > one week.
- Subjects or their legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable, effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.
Who cannot join
- Criteria for exclusion from this study will be any of the following:
- Subjects who do not have bipolar disorder by DSM-IV-TR criteria.
- Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
- Subjects whose bipolar manic symptoms are presently less than mild (CGI-BP < 2) or more than markedly ill (CGI-BP > 5 or YMRS > 21)
- Subjects who have severe depressive symptoms (IDS > 39 ) or psychotic features (as defined in DSM-IV)
- Subjects with clinically significant suicidal or homicidal ideation.
Show all 12Show fewer
- Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance use disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
- Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
- Subjects who are allergic to or who have demonstrated hypersensitivity to quetiapine.
- Women who are pregnant or nursing.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
- Subjects who have a history of neuroleptic malignant syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0559
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania.
Read the detailed description
Methods and Procedures
This is a single center, eight-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 40 outpatients with bipolar disorder types I, II, or NOS by DSM-IV-TR criteria who also have moderate-to-severe hypomanic symptoms or mild manic symptoms (defined as a score of > 3 but <5 on the Clinical Global Impressions Scale Modified for Bipolar Disorder [CGI-BP]). Subjects may have concurrent depressive or anxiety symptoms or syndromes, but they may not have psychotic features (as defined in DSM-IV) or substance dependence. The primary outcome measure will be change in the Young Mania Rating Scale (YMRS) scores. Secondary outcome measures will include the total of the YMRS and the Inventory for Depressive Symptoms (IDS), the IDS alone, the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-BP, the Global Assessment of Functioning (GAF), the Life Functioning Questionnaire (LFQ), and the Sheehan Disability Scale (DSD). Of note, the YMRS-IDS total reflects a novel means of assessing total affective burden. Also, IDS will be used to assess depressive symptoms because of our experience in the Stanley Foundation Bipolar Network indicating that this scale better assesses the signs and symptoms of bipolar depression as compared to both the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Depression Scale (MADRAS). The LFQ is a validated gender neutral scale specifically designed to assess functional outcome in bipolar disorder. The Abnormal Involuntary Movement Scale (AIMS), Simpson Angus Scale (SAS), and Barnes Akathisia Scale (BARS), will be used to assess for degree and severity of extrapyramidal side effects experienced.
Data Analysis and Data Monitoring
All subjects with observations available from the baseline and at least one post-baseline visit will be included in analyses. The primary outcome measure will be the change in YMRS scale scores from baseline to last observation. The difference in YMRS change between treatment groups will be tested for significance (alpha=0.05, two-tailed) using an independent-samples t-test. Measures of change in total affective burden, depressive and anxiety symptoms, global improvement, use of adjunctive anxiolytic and hypnotic medication, adherence to study medication, frequency and severity of side effects, and reasons for early termination will also be analyzed. The final dose achieved by each subject will be correlated with scale score change. Tolerability will be assessed based on adverse experiences, clinical laboratory tests, vital signs (blood pressure and pulse), weight, and discontinuation rates.
- Conditions
- Bipolar Disorder
- Being tested
- Quetiapine
- Keywords
- currently experiencing hypomania or mild mania
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Oral dosing: 50mg (Day 1), 100mg (Day 2), 150mg (Day 3), 200mg (Day 4), followed by flexible dosing from 50mg to 800mg through day 56.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in manic symptoms (as measured by Young Mania Rating Scale)
Measured: baseline to endpoint
Secondary outcomes (1)
Change in total burden of affective symptoms, depressive symptoms alone, and anxiety symptoms alone; change in clinical global improvement; adherence with study medication; and degree and severity of side effects experienced.
Measured: baseline to endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startFeb 2004
- Primary completionDec 2007
- Study completionDec 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, University of Cincinnati
- Investigators
- Susan L. McElroy, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277667
- Sponsor's protocol ID
- IRUSQUET0302
- Status last verified
- Mar 2009
- First submitted
- 12 Jan 2006
- Last updated
- 13 Mar 2009
- Results posted
- No
Publications
McElroy SL, Martens BE, Winstanley EL, Creech R, Malhotra S, Keck PE Jr. Placebo-controlled study of quetiapine monotherapy in ambulatory bipolar spectrum disorder with moderate-to-severe hypomania or mild mania. J Affect Disord. 2010 Jul;124(1-2):157-63. doi: 10.1016/j.jad.2009.11.014. Epub 2009 Dec 5.
PubMed 19963274
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
- ClinicalTrials.gov ID
- NCT00277667
- Acronym / sponsor ID
- IRUSQUET0302
- Conditions
- Bipolar Disorder
- Keywords
- currently experiencing hypomania or mild mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- AstraZeneca, University of Cincinnati
- Study start
- Feb 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Jan 2006 (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 research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania.
Detailed description
Methods and Procedures
This is a single center, eight-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 40 outpatients with bipolar disorder types I, II, or NOS by DSM-IV-TR criteria who also have moderate-to-severe hypomanic symptoms or mild manic symptoms (defined as a score of > 3 but <5 on the Clinical Global Impressions Scale Modified for Bipolar Disorder [CGI-BP]). Subjects may have concurrent depressive or anxiety symptoms or syndromes, but they may not have psychotic features (as defined in DSM-IV) or substance dependence. The primary outcome measure will be change in the Young Mania Rating Scale (YMRS) scores. Secondary outcome measures will include the total of the YMRS and the Inventory for Depressive Symptoms (IDS), the IDS alone, the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-BP, the Global Assessment of Functioning (GAF), the Life Functioning Questionnaire (LFQ), and the Sheehan Disability Scale (DSD). Of note, the YMRS-IDS total reflects a novel means of assessing total affective burden. Also, IDS will be used to assess depressive symptoms because of our experience in the Stanley Foundation Bipolar Network indicating that this scale better assesses the signs and symptoms of bipolar depression as compared to both the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Depression Scale (MADRAS). The LFQ is a validated gender neutral scale specifically designed to assess functional outcome in bipolar disorder. The Abnormal Involuntary Movement Scale (AIMS), Simpson Angus Scale (SAS), and Barnes Akathisia Scale (BARS), will be used to assess for degree and severity of extrapyramidal side effects experienced.
Data Analysis and Data Monitoring
All subjects with observations available from the baseline and at least one post-baseline visit will be included in analyses. The primary outcome measure will be the change in YMRS scale scores from baseline to last observation. The difference in YMRS change between treatment groups will be tested for significance (alpha=0.05, two-tailed) using an independent-samples t-test. Measures of change in total affective burden, depressive and anxiety symptoms, global improvement, use of adjunctive anxiolytic and hypnotic medication, adherence to study medication, frequency and severity of side effects, and reasons for early termination will also be analyzed. The final dose achieved by each subject will be correlated with scale score change. Tolerability will be assessed based on adverse experiences, clinical laboratory tests, vital signs (blood pressure and pulse), weight, and discontinuation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 18 years of age or older.
- Subjects must have bipolar I, II, or not otherwise specified (NOS) disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. Of note, bipolar NOS disorder will include subjects with either recurrent or sporadic brief hypomanias (hypomanias of 1 to 3 days in duration).
- Subjects must have moderate-to-severe hypomanic symptoms or mild manic symptoms that must be clinically significant (at least mild) but no worse than moderately severe, defined as a CGI-BP scale for mania > 3 and < 5, on at least 2 assessment days at least 3 days apart during the screening phase.
- Subjects must not be receiving mood stabilizing, antidepressant, or antipsychotic medication for > one week.
- Subjects or their legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained.
Key exclusion criteria (12 listed)
- Subjects who do not have bipolar disorder by DSM-IV-TR criteria.
- Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
- Subjects whose bipolar manic symptoms are presently less than mild (CGI-BP < 2) or more than markedly ill (CGI-BP > 5 or YMRS > 21)
- Subjects who have severe depressive symptoms (IDS > 39 ) or psychotic features (as defined in DSM-IV)
- Subjects with clinically significant suicidal or homicidal ideation.
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 |
|---|---|---|
| QuetiapineOral dosing: 50mg (Day 1), 100mg (Day 2), 150mg (Day 3), 200mg (Day 4), followed by flexible dosing from 50mg to 800mg through day 56. | Drug | – |
Primary outcome
Change in manic symptoms (as measured by Young Mania Rating Scale)
Time frame: baseline to endpoint
1 secondary outcome
Change in total burden of affective symptoms, depressive symptoms alone, and anxiety symptoms alone; change in clinical global improvement; adherence with study medication; and degree and severity of side effects experienced.
Time frame: baseline to endpoint
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 13 Mar 2009.
- Derived from this study: PubMed 19963274McElroy SL, Martens BE, Winstanley EL, Creech R, Malhotra S, Keck PE Jr. Placebo-controlled study of quetiapine monotherapy in ambulatory bipolar spectrum disorder with moderate-to-severe hypomania or mild mania. J Affect Disord. 2010 Jul;124(1-2):157-63. doi: 10.1016/j.jad.2009.11.014. Epub 2009 Dec 5.
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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.
Susan L. McElroy, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine in people with Bipolar Disorder, run by Lindner Center of HOPE 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 6 inclusion and 12 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 13 Mar 2009. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in manic symptoms (as measured by Young Mania Rating Scale) (time frame: baseline to endpoint). 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 NCT00277667, 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 13 Mar 2009.