Bipolar DepressionPhase 4NCT01587066
Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression
A Phase 4 study testing Quetiapine fumarate and Divalproex sodium in people with Bipolar Depression, run by Bo-Hyun Yoon at 1 site in South Korea.
Trial summary
Quetiapine is one of atypical antipsychotics with good efficacy and better side effect profiles than conventional antipsychotics, so it is being widely used beyond the treatment of schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Quetiapine fumarate and Divalproex sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Sep 2011
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- A diagnosis of Bipolar depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females and males aged 20 to 65 years
- 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
- HAM-D score at Visit 0 and Visit 1 should be above 20.
- Willingness to adhere to the schedule of assessments
- Able and willing to comply with self-administration of study drug, or have consistent help or support available
Who cannot join
- Pregnancy or lactation
- Any DSM-IV Axis 1 disorder not defined in the inclusion criteria
- 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 or divalproex, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erγthromycin， clarithromycin, troleandomycin, indinavir, nelfinavir，ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin， St. John's Wort, and glucocorticoids
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- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrollment (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 8 weeks prior to enrollment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e,g, congestive heart failure,angina pectoris, hypertension) as judged by the investigator Invo1vement in the planning and conduct of the study
- Previous enrollment or randomisation of treatment in the present study.
- Participation in another drug trial within 8 weeks prior enrollment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrolment glycosylated hemoglobin (HbAlc) > 8.5%
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
- Not under physician care for DM
- Physician responsib1e for patient's DM care has not indicated that patient's DM is controlled
- Physician responsible for patient's DM care has not approved patient's participation in the study
- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study
- An absolute neutrophil count (ANC) of s 1.5 x 109 per liter
Trial locations and contacts
1 site in 1 country.
About this study
Quetiapine is one of atypical antipsychotics with good efficacy and better side effect profiles than conventional antipsychotics, so it is being widely used beyond the treatment of schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is an effective and well-tolerated treatment for depressive episodes in bipolar disorder. However, most c1inicians did not have confidence with quetiapine monotherapy yet, and most practice guidelines recommend the monotherapy with mood stabilizer as the first-line treatment. The Korean medication algorithm for bipolar disorder published in 2006 also recommend the monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild to moderate depressive episode of bipolar disorder.
Therefore, the aim of this study is investigating the efficacy and safety of quetiapine monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators are going to reveal the quality of sleep and quality of life, of the two groups of patients.
- Conditions
- Bipolar Depression
- Being tested
- Quetiapine fumarate, Divalproex sodium
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
Also called Seroquel XR, Quetiapine fumarate
Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
Divalproex sodiumDrug
Also called Depakote XR, Divalproex sodium
Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine fumarate | Active comparator | Not described Receives: Drug: Quetiapine fumarate |
| Divalproex sodium | Active comparator | Not described Receives: Drug: Divalproex sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
In between the two drugs at baseline MADRS score change at 8 weeks comparison.
Quetiapine fumarate XR vs. Divalproex sodium treatment compared clinical outcomes in bipolar depression.
Measured: one year
Secondary outcomes (1)
Improvement compared with the Number of subjects responding to drug and reliability, and tolerability between the two drugs, quality of sleep and quality of life
Improvement compared with the Number of subjects responding to drug and reliability, and tolerability between the two drugs, quality of sleep and quality of life.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo-Hyun Yoon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo-Hyun Yoon, Naju National Hospital
- Investigators
- Bo-Hyun Yoon, Doctor, Principal investigator, Naju National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587066
- Sponsor's protocol ID
- D1443L00059
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression
- ClinicalTrials.gov ID
- NCT01587066
- Acronym / sponsor ID
- D1443L00059
- Conditions
- Bipolar Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bo-Hyun YoonUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 27 Apr 2012 (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.
Quetiapine is one of atypical antipsychotics with good efficacy and better side effect profiles than conventional antipsychotics, so it is being widely used beyond the treatment of schizophrenia. Recently, the BOLDER I and II study showed that quetiapine monotherapy is an effective and well-tolerated treatment for depressive episodes in bipolar disorder. However, most c1inicians did not have confidence with quetiapine monotherapy yet, and most practice guidelines recommend the monotherapy with mood stabilizer as the first-line treatment. The Korean medication algorithm for bipolar disorder published in 2006 also recommend the monotherapy with lithium, divalproex, or lamotrigine in the treatment of mild to moderate depressive episode of bipolar disorder.
Therefore, the aim of this study is investigating the efficacy and safety of quetiapine monotherapy when compared with mood stabilizer monotherapy. In addition, the investigators are going to reveal the quality of sleep and quality of life, of the two groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine fumarate | Active comparator | Drug: Quetiapine fumarate |
| Divalproex sodium | Active comparator | Drug: Divalproex sodium |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of written informed consent
- A diagnosis of Bipolar depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Females and males aged 20 to 65 years
- 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
Key exclusion criteria (22 listed)
- Pregnancy or lactation
- Any DSM-IV Axis 1 disorder not defined in the inclusion criteria
- 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 or divalproex, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erγthromycin， clarithromycin, troleandomycin, indinavir, nelfinavir，ritonavir, fluvoxamine and saquinavir
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 fumarateAlso: Seroquel XR, Quetiapine fumarateEfficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression | Drug | Quetiapine fumarate |
| Divalproex sodiumAlso: Depakote XR, Divalproex sodiumEfficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression | Drug | Divalproex sodium |
Primary outcome
In between the two drugs at baseline MADRS score change at 8 weeks comparison.
Time frame: one year
Quetiapine fumarate XR vs. Divalproex sodium treatment compared clinical outcomes in bipolar depression.
1 secondary outcome
Improvement compared with the Number of subjects responding to drug and reliability, and tolerability between the two drugs, quality of sleep and quality of life
Time frame: one year
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 27 Apr 2012.
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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.
Bo-Hyun Yoon, Doctor principal investigator
Naju National Hospital
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 Quetiapine fumarate and Divalproex sodium in people with Bipolar Depression, run by Bo-Hyun Yoon 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 8 inclusion and 22 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 27 Apr 2012. 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 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 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?
In between the two drugs at baseline MADRS score change at 8 weeks comparison. (time frame: one year). 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 27 Apr 2012.