Bipolar DisorderNCT00742638
To Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.
A study testing Quetiapine fumarate and Sodium valproate in people with Bipolar Disorder, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is an open label, randomised, parallel-group study to compare the efficacy and safety of quetiapine and valproate used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. 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 and Sodium valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Aug 2010
- Phase
- Interventional
- 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 for study participation, signed by the patient's legal guardian
- Aged between 18 and 65 (inclusive)
- Is hospitalized in a psychiatric unit with an acute manic episode of bipolar disorder defined by CCMD-3 criteria i.e. [31.2] bipolar disorder whose current status is mania without psychotic symptom or [31.3] bipolar disorder whose current status is mania with psychotic symptom
- Both at screening and at randomization (Day 1), had a YMRS total score of at least 20
- Be able to understand and comply with the requirements of the study, judged by the investigator
Who cannot join
- Manic index episode judged to be the direct physiological consequence of a medical condition or treatment.
- These conditions included:
- degenerative neurological conditions (e.g. Parkinson's disease, Huntington's disease),
- cerebrovascular disease (e.g., stroke),
- metabolic conditions (e.g., Vitamin B12 deficiency),
- autoimmune conditions (e.g., systemic lupus erythematosus),
Show all 36Show fewer
- viral or other infections (e.g., hepatitis, mononucleosis, human immunodeficiency),
- certain cancers.
- Manic index episode judged to be the direct physiological effect of a substance of abuse, including intoxication with or withdrawal from alcohol, amphetamine and related substances, cocaine, sedatives, hypnotics, or anxiolytics; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances.
- Patients who met CCMD-3 criteria for rapid cycling: at least 4 episodes of a mood disturbance in the previous 12 months that meet criteria for a hypomanic/manic or nonmajor depression/depression, or mixed episode
- Known intolerance or lack of response to quetiapine or valproate, as judged by the investigator
- Known or suspected hypersensitivity to quetiapine or valproate
- Known lack of response to clozapine
- Use of clozapine within 28 days before randomization (Day 1)
- Women in pregnancy or lactation, or female of childbearing potential without appropriate birth control measures
- Substance or alcohol dependence (except for nicotine dependence), as defined in CCMD-3, within 1 month before randomisation (Day 1).
- Continuous daily use of benzodiazepines during the month preceding screening.
- Receipt of electroconvulsive therapy (ECT) within 30 days prior to randomisation (Day 1).
- Use of antidepressant(s) during the screening period (Day -7 to Day 1) or within a period of 5 half-lives of the drug(s) prior to randomisation (Day 1).
- Use of long-acting anti-psychotic medication within 30 days prior to randomisation (Day 1)
- Thyroid-stimulating hormone concentration more than 10% above the upper limit of the normal range, regardless of treatment for hypothyroidism or hyperthyroidism.
- Use of any potent cytochrome P450 3A4 inhibitors in the 14 days preceding randomization (Day 1), e.g., ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir.
- Use of potent cytochrome P450 inducers (e.g. Phenytoin, carbamazepine, barbiturates, rifampin, glucocorticoids, St. John's Wort) in the 14 days preceding randomisation (Day 1).
- Renal, cardiovascular, hepatic, haematological, endocrine, congestive heart failure, or other disease or clinical finding that was unstable or in the opinion of the investigator would be negatively affected by study medication or that would affect study medication.
- Patients with diabetes mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrolment HbA1c > 8.5%
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
- Not under care of physician responsible for patient's DM care
- Physician responsible 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
- Participation in another clinical study within 4 weeks of randomisation (Day 1).
- Lack of response in previous systemic treatment with lithium and/or quetiapine.
- Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
- An absolute neutrophil count (ANC) of < 1.5 x 109/L
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yao Peifen, Prof., 13916683828, ypf93@163.com
Yao Peifen, Professor
About this study
Official title: An Open Label, Randomised, Valproate-Controlled Study to Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.
This is an open label, randomised, parallel-group study to compare the efficacy and safety of quetiapine and valproate used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or valproate group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol.
At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
Read the detailed description
The rationale for using the quetiapine to treat patients with acute mania is multifold. A potential major advantage for quetiapine is its demonstrated tolerability. Because of the low incidence of EPS, quetiapine should be better tolerated than other antipsychotic medications in this sensitive patient population. The limited potential for weight gain and prolactin elevation may promote long-term treatment compliance.
The effect of quetiapine alone or adjunctive with mood stabilizers in the treatment of acute mania in patients with bipolar disorder has been confirmed through 4 phase III clinical trials (8,9). Based on the results of these clinical trials, the use of Seroquel in the acute mania of bipolar disorder has been approved in US, UK and other major markets in Europe. Quetiapine is also been recommended as alternative therapy for acute mania treatment in the practice guideline (10). The present study is to assess the effectiveness of quetiapine and valproate in the treatment of Chinese patients with acute mania over a treatment period of 4 weeks. Primary objective The primary objective of the study is to evaluate the effectiveness of quetiapine fumarate used as monotherapy in the treatment of symptoms of acute mania in patients with bipolar disorder, by evaluation of the change from baseline in YMRS total score at Day 28 (LOCF).
Secondary objectives
The secondary objectives of the study are to evaluate the following:
- The effectiveness of quetiapine used as monotherapy to treat symptoms in patients with acute mania by evaluation of YMRS/CGI response rate at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to improve clinical status in patients with acute mania by evaluation of change from baseline in CGI-S score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat depressive symptoms in patients with acute mania by evaluation of change from baseline in MADRS total score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat psychotic symptoms in patients with acute mania by evaluation of change from baseline in PANSS total score at Day 28 (LOCF)
- The safety and tolerability of quetiapine used as monotherapy to treat symptoms in patients with acute mania
- Conditions
- Bipolar Disorder
- Being tested
- Quetiapine fumarate, Sodium valproate
- Keywords
- CCMD-3,, CRF,, EPS,, GCP,, ICH,, ITT,, LOCF,, MADRS,, PANSS,, YMRS., Acute, manic, patients, with, bipolar, disorder
- Medical subject headings
- Bipolar Disorder, Mania, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
Investigational product: quetiapine fumarate tablet 25 mg and 200 mg
Sodium valproateDrug
Sodium valproate tablet 200 mg
| Study group | Role | What they receive |
|---|---|---|
| The arm 1 | Experimental | Quetiapine fumarate tablet:25mg and 200mg Receives: Drug: Quetiapine fumarate |
| The arm 2 | Active comparator | Sodium valproate tablet 200mg Receives: Drug: Sodium valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF).
Measured: Four weeks
Secondary outcomes (1)
These changes from baseline in PANSS,MADRS, CGI total score at Day 28.
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 posted28 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2010 (estimated)
- Study completionAug 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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742638
- Sponsor's protocol ID
- D1443L00057
- Status last verified
- Aug 2008
- First submitted
- 25 Aug 2008
- Last updated
- 28 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomised, Valproate-Controlled Study to Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.
- ClinicalTrials.gov ID
- NCT00742638
- Acronym / sponsor ID
- D1443L00057
- Conditions
- Bipolar Disorder
- Keywords
- CCMD-3,, CRF,, EPS,, GCP,, ICH,, ITT,, LOCF,, MADRS,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 28 Aug 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.
This is an open label, randomised, parallel-group study to compare the efficacy and safety of quetiapine and valproate used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or valproate group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol.
At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
Detailed description
The rationale for using the quetiapine to treat patients with acute mania is multifold. A potential major advantage for quetiapine is its demonstrated tolerability. Because of the low incidence of EPS, quetiapine should be better tolerated than other antipsychotic medications in this sensitive patient population. The limited potential for weight gain and prolactin elevation may promote long-term treatment compliance.
The effect of quetiapine alone or adjunctive with mood stabilizers in the treatment of acute mania in patients with bipolar disorder has been confirmed through 4 phase III clinical trials (8,9). Based on the results of these clinical trials, the use of Seroquel in the acute mania of bipolar disorder has been approved in US, UK and other major markets in Europe. Quetiapine is also been recommended as alternative therapy for acute mania treatment in the practice guideline (10). The present study is to assess the effectiveness of quetiapine and valproate in the treatment of Chinese patients with acute mania over a treatment period of 4 weeks. Primary objective The primary objective of the study is to evaluate the effectiveness of quetiapine fumarate used as monotherapy in the treatment of symptoms of acute mania in patients with bipolar disorder, by evaluation of the change from baseline in YMRS total score at Day 28 (LOCF).
Secondary objectives
The secondary objectives of the study are to evaluate the following:
- The effectiveness of quetiapine used as monotherapy to treat symptoms in patients with acute mania by evaluation of YMRS/CGI response rate at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to improve clinical status in patients with acute mania by evaluation of change from baseline in CGI-S score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat depressive symptoms in patients with acute mania by evaluation of change from baseline in MADRS total score at Day 28 (LOCF)
- The effectiveness of quetiapine used as monotherapy to treat psychotic symptoms in patients with acute mania by evaluation of change from baseline in PANSS total score at Day 28 (LOCF)
- The safety and tolerability of quetiapine used as monotherapy to treat symptoms in patients with acute mania
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The arm 1 | Experimental | Drug: Quetiapine fumarateQuetiapine fumarate tablet:25mg and 200mg |
| The arm 2 | Active comparator | Drug: Sodium valproateSodium valproate tablet 200mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent for study participation, signed by the patient's legal guardian
- Aged between 18 and 65 (inclusive)
- Is hospitalized in a psychiatric unit with an acute manic episode of bipolar disorder defined by CCMD-3 criteria i.e. [31.2] bipolar disorder whose current status is mania without psychotic symptom or [31.3] bipolar disorder whose current status is mania with psychotic symptom
- Both at screening and at randomization (Day 1), had a YMRS total score of at least 20
- Be able to understand and comply with the requirements of the study, judged by the investigator
Key exclusion criteria (36 listed)
- Manic index episode judged to be the direct physiological consequence of a medical condition or treatment.
- These conditions included:
- Manic index episode judged to be the direct physiological effect of a substance of abuse, including intoxication with or withdrawal from alcohol, amphetamine and related substances, cocaine, sedatives, hypnotics, or anxiolytics; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances.
- Patients who met CCMD-3 criteria for rapid cycling: at least 4 episodes of a mood disturbance in the previous 12 months that meet criteria for a hypomanic/manic or nonmajor depression/depression, or mixed episode
- Known intolerance or lack of response to quetiapine or valproate, as judged by the investigator
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 fumarateInvestigational product: quetiapine fumarate tablet 25 mg and 200 mg | Drug | The arm 1 |
| Sodium valproateSodium valproate tablet 200 mg | Drug | The arm 2 |
Primary outcome
The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF).
Time frame: Four weeks
1 secondary outcome
These changes from baseline in PANSS,MADRS, CGI total score at Day 28.
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 28 Aug 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quetiapine fumarate and Sodium valproate in people with Bipolar Disorder, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 36 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 28 Aug 2008. 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.
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 Yao Pei Fen, Prof. (13916683828, ypf93@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF). (time frame: Four weeks). 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 28 Aug 2008.