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

NCT00742638 | Unknown DMC

• 1 other identifier: D1443L00057
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder

Keywords

CCMD-3,; CRF,; EPS,; GCP,; ICH,; ITT,; LOCF,; MADRS,; PANSS,; YMRS.; Acute; manic; patients; with; bipolar; disorder

Outcome Measures

Primary Outcomes (1)

• The outcome measure is the change from baseline in YMRS total score at Day 28 (LOCF).

  Four weeks

Secondary Outcomes (1)

• These changes from baseline in PANSS,MADRS, CGI total score at Day 28.

  28 days

Study Arms (2)

The arm 1

EXPERIMENTAL

Quetiapine fumarate tablet:25mg and 200mg

Drug: Quetiapine fumarate

The arm 2

ACTIVE COMPARATOR

Sodium valproate tablet 200mg

Drug: Sodium valproate

Interventions

Quetiapine fumarate DRUG

Investigational product: quetiapine fumarate tablet 25 mg and 200 mg

The arm 1

Sodium valproate DRUG

Sodium valproate tablet 200 mg

The arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Mania; Disease

Interventions

Quetiapine Fumarate; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Yao Pei Fen, Prof.

CONTACT

13916683828; ypf93@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 28, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

CN (1)