To Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00742638
First received: August 25, 2008
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Bipolar Disorder
Drug: Quetiapine fumarate
Drug: Sodium valproate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF). [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • These changes from baseline in PANSS,MADRS, CGI total score at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The arm 1
Quetiapine fumarate tablet:25mg and 200mg
Drug: Quetiapine fumarate
Investigational product: quetiapine fumarate tablet 25 mg and 200 mg
Active Comparator: The arm 2
Sodium valproate tablet 200mg
Drug: Sodium valproate
Sodium valproate tablet 200 mg

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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),
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742638

Contacts
Contact: Yao Pei Fen, Prof. 13916683828 ypf93@163.com

Locations
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Yao Peifen, Prof.    13916683828    ypf93@163.com   
Principal Investigator: Yao Peifen, Professor         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Yao Peifen, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT00742638     History of Changes
Other Study ID Numbers: D1443L00057
Study First Received: August 25, 2008
Last Updated: August 26, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
CCMD-3,
CRF,
EPS,
GCP,
ICH,
ITT,
LOCF,
MADRS,
PANSS,
YMRS.
Acute
manic
patients
with
bipolar
disorder

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Quetiapine
Valproic Acid
Anticonvulsants
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014