Bipolar DisorderPhase 4NCT00837343
A Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder
A Phase 4 study testing quetiapine fumarate tablet (Seroquel) in people with Bipolar Disorder, run by Guangzhou Mental Hospital at 1 site in China.
Trial summary
Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of severe mental disorder involving both mania or hypomania and depression episode, with lifetime prevalence between 1.2 - 1.6%. 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?
- quetiapine fumarate tablet (Seroquel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent was submitted by subjects or their legal guardian
- Bipolar disorder (296.0x, 296.4x) is diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders - Patient Edition (SCID), based on the 4th edition of US Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Aged between 18 and 65, male and female, Han nationality
- In the acute phase of mania episode and YMRS total score is at least 22 at baseline.
- The following drugs (lithium carbonate, sodium valproate, risperidone or olanzapine) were received as previous maintain treatment( monotherapy or combination therapy) in adequate dose according to label within three months before this mania episode.
- Child-bearing potential female patients should conduct urine pregnancy test (HCG) at the enrolment, and the result should be negative; and also willing to take contraception measures during the study period
- Be able to understand and comply with the requirements of the study
Who cannot join
- Women in pregnancy or lactation
- The duration of this mania episode is at most 2 weeks at enrollment.
- DSM-IV Axis I Disorders except bipolar disorder (296.0x, 296.4x)
- Patients with symptoms of obvious suicide (MADRS No. 10 score ≥4), self-injured or harmful to others, as judged by the investigators
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigators
- Patients with non-compliance by his history as judged by the investigators
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- Use of any potent cytochrome P450 3A4 inhibitors in the 14 days preceding randomization, including but not limited as ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir
- Use of potent cytochrome P450 inducers in the 14 days preceding randomization, including but not limited as phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- long-acting antipsychotic drug was injected within 1 injection interval (prolonged acting injection) before randomization
- Use of clozapine in the 28 days preceding randomization
- Substance or alcohol dependence according to the DSM-IV criteria at randomization (except complete recovered, and caffeine and nicotine dependence)
- Dependence for the following drugs according to the DSM-IV standard at 4 weeks preceding randomization: opioids, amphetamine, barbiturates, cocaine, cannabis, or hallucinogens
- Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
- Clinical evidence for the relevant diseases (e.g. renal or hepatic dysfunction, severe coronary heart disease, cerebrovascular disease, hepatitis and acquired immunodeficiency syndrome (AIDS))
- Unstable conditions (e.g. hypertension, congestive heart failure, unstable angina pectoris) or in the opinion of the investigator would be negatively affected by study medication or that would affect study medication, or has a medical history of chronic body disease.
- Medical history with seizure disorder, except for febrile convulsion
- Persons involved in the study design and conducting (suitable for the working staff in AstraZeneca and study site)
- Participation in another clinical study within 4 weeks (or longer time according to the local requirement) of randomisation
- Patients with diabetes mellitus (DM)
- An absolute neutrophil count (ANC) of < 1.5 x 109/L
- Thyroid-stimulating hormone level is more than 10% above the upper limit of the normal range, regardless of treatment for hypothyroidism or hyperthyroidism.
- Abnormal ECG with clinical significance at enrollment indicating abnormal function in the heart, as judged by the investigator
- Previous enrolment in the present study.
Trial locations and contacts
1 site in 1 country.
Dong Xiao Chen, Master contact
China1 site, 1 recruiting
- Recruiting
Guangzhou Mental Hospital
Guangzhou, China/Guangdong Province
Jie Li, Professor, 020-81801909, biglijie@163.com
About this study
Official title: An Open Label, Multicenter, Single Arm, 4-Week Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder
Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of severe mental disorder involving both mania or hypomania and depression episode, with lifetime prevalence between 1.2 - 1.6%. The hygienic burden of bipolar disorder is high, and its disease burden lies in top 10 position among the population of 15 - 44 years of old patients and concomitant with relative high suicide rate (10 - 15%) and mutilation rate, as reported by the World Health Organization (WHO) 2001 Annual Report. Drug treatment is one of the main treatment methods for this kind of disease, and the dose selected will interfere the efficacy and prognosis of the patient.
Quetiapine fumarate (Seroquel) is a dibenzothiazepine derivative, which is widely used in the world. It has the indications in schizophrenia, bipolar mania and depression approved by FDA. Quetiapine fumarate has been used in China for almost 10 years, which is in the treatment of schizophrenia. The indication of bipolar mania has been approved by SFDA recently. Exploration of the relationship between the dose and efficacy has been a hot spot in the clinical practice as the drug has a broad action spectrum and wide dose range (200mg/d-800mg/d).
Brain-derived neurotrophic factor (BDNF) plays an important role in the pathophysiology of bipolar disorder. Some clinical studies indicate the blood BDNF level decreased during the depression phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the depression; and the same phenomenon was found, i.e. the blood BDNF level decreased during the manic phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the mania. Quetiapine fumarate was found to reduce the decreasing of the expression of BDNF in the rat hippocampus and brain mantle in some animal experiments, indicating quetiapine fumarate has the possibility on potential interfering BDNF in the treatment. However, few study on comparison of the blood BDNF level between pre and post treatment in the bipolar disorder was conducted.
Read the detailed description
This is a multicenter, open label, 4-week study. Study subjects are defined in Chinese Han nationality patients with acute mania of bipolar disorder (inpatients or outpatients). The screening phase is up to 7 days. The eligible patients in the screening phase can be enrolled into the treatment phase, the target dose is 400-800mg/day, and treatment period will last for 4 weeks. The objective is to evaluate the efficacy of quetiapine fumarate switching from other drugs used as monotherapy in the treatment of acute mania with bipolar disorder, and the relationship between the serum BDNF and quetiapine fumarate.
- Conditions
- Bipolar Disorder
- Being tested
- quetiapine fumarate tablet (Seroquel)
- Keywords
- Bipolar disorder
- 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 fumarate tablet (Seroquel)Drug
Investigational product: quetiapine fumarate tablet (Seroquel) , 25 mg, 200 mg, 300mg, manufactured by AstraZeneca.The total daily doses of quetiapine fumarate will be increased to 600mg/d on the 6th since enrolment day. At day 7 or later, the dose can be adjusted in the range of 400- 800mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine Fumarate arm | Experimental | Quetiapine Fumarate arm Receives: Drug: quetiapine fumarate tablet (Seroquel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable for this study is the YMRS total score change from baseline to Day 28 (LOCF).
Measured: 28 days
Secondary outcomes (3)
To evaluate the effectiveness of quetiapine fumarate
Measured: 28 days
To evaluate the relationship between the serum brain-derived neurotrophic factor and quetiapine fumarate
Measured: 28 days
To evaluate the safety and tolerability of quetiapine fumarate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Mental Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou mental Hospital Attached to Guangzhou Civil Affairs Bureau
- Investigators
- Jie Li, Professor, Principal investigator, Guangzhou Mental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837343
- Sponsor's protocol ID
- D1443L00070
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Single Arm, 4-Week Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00837343
- Acronym / sponsor ID
- D1443L00070
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou Mental HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou mental Hospital Attached to Guangzhou Civil Affairs Bureau
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 5 Feb 2009 (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.
Bipolar disorder (BD) is also named as a bipolar affective disorder, belonging to a kind of severe mental disorder involving both mania or hypomania and depression episode, with lifetime prevalence between 1.2 - 1.6%. The hygienic burden of bipolar disorder is high, and its disease burden lies in top 10 position among the population of 15 - 44 years of old patients and concomitant with relative high suicide rate (10 - 15%) and mutilation rate, as reported by the World Health Organization (WHO) 2001 Annual Report. Drug treatment is one of the main treatment methods for this kind of disease, and the dose selected will interfere the efficacy and prognosis of the patient.
Quetiapine fumarate (Seroquel) is a dibenzothiazepine derivative, which is widely used in the world. It has the indications in schizophrenia, bipolar mania and depression approved by FDA. Quetiapine fumarate has been used in China for almost 10 years, which is in the treatment of schizophrenia. The indication of bipolar mania has been approved by SFDA recently. Exploration of the relationship between the dose and efficacy has been a hot spot in the clinical practice as the drug has a broad action spectrum and wide dose range (200mg/d-800mg/d).
Brain-derived neurotrophic factor (BDNF) plays an important role in the pathophysiology of bipolar disorder. Some clinical studies indicate the blood BDNF level decreased during the depression phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the depression; and the same phenomenon was found, i.e. the blood BDNF level decreased during the manic phase in the bipolar disorder, and the blood BDNF level is negative proportional to the severity of the mania. Quetiapine fumarate was found to reduce the decreasing of the expression of BDNF in the rat hippocampus and brain mantle in some animal experiments, indicating quetiapine fumarate has the possibility on potential interfering BDNF in the treatment. However, few study on comparison of the blood BDNF level between pre and post treatment in the bipolar disorder was conducted.
Detailed description
This is a multicenter, open label, 4-week study. Study subjects are defined in Chinese Han nationality patients with acute mania of bipolar disorder (inpatients or outpatients). The screening phase is up to 7 days. The eligible patients in the screening phase can be enrolled into the treatment phase, the target dose is 400-800mg/day, and treatment period will last for 4 weeks. The objective is to evaluate the efficacy of quetiapine fumarate switching from other drugs used as monotherapy in the treatment of acute mania with bipolar disorder, and the relationship between the serum BDNF and quetiapine fumarate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine Fumarate arm | Experimental | Drug: quetiapine fumarate tablet (Seroquel)Quetiapine Fumarate arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent was submitted by subjects or their legal guardian
- Bipolar disorder (296.0x, 296.4x) is diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders - Patient Edition (SCID), based on the 4th edition of US Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- Aged between 18 and 65, male and female, Han nationality
- In the acute phase of mania episode and YMRS total score is at least 22 at baseline.
- The following drugs (lithium carbonate, sodium valproate, risperidone or olanzapine) were received as previous maintain treatment( monotherapy or combination therapy) in adequate dose according to label within three months before this mania episode.
Key exclusion criteria (23 listed)
- Women in pregnancy or lactation
- The duration of this mania episode is at most 2 weeks at enrollment.
- DSM-IV Axis I Disorders except bipolar disorder (296.0x, 296.4x)
- Patients with symptoms of obvious suicide (MADRS No. 10 score ≥4), self-injured or harmful to others, as judged by the investigators
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigators
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 tablet (Seroquel)Investigational product: quetiapine fumarate tablet (Seroquel) , 25 mg, 200 mg, 300mg, manufactured by AstraZeneca.The total daily doses of quetiapine fumarate will be increased to 600mg/d on the 6th since enrolment day. At day 7 or later, the dose can be adjusted in the range of 400- 800mg/day. | Drug | Quetiapine Fumarate arm |
Primary outcome
The primary efficacy variable for this study is the YMRS total score change from baseline to Day 28 (LOCF).
Time frame: 28 days
3 secondary outcomes
To evaluate the effectiveness of quetiapine fumarate
Time frame: 28 days
To evaluate the relationship between the serum brain-derived neurotrophic factor and quetiapine fumarate
Time frame: 28 days
To evaluate the safety and tolerability of quetiapine fumarate
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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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.
Dong Xiao Chen, Master contact
Jie Li, Professor principal investigator
Guangzhou Mental 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 tablet (Seroquel) in people with Bipolar Disorder, run by Guangzhou Mental Hospital at 1 site in China.
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 23 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: status not confirmed, as of the sponsor's last update on 5 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, Professor (020-81801909, biglijie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable for this study is the YMRS total score change from baseline to Day 28 (LOCF). (time frame: 28 days). 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 5 Feb 2009.