Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bo-Hyun Yoon, Naju National Hospital
ClinicalTrials.gov Identifier:
NCT01587066
First received: April 25, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: Quetiapine fumarate
Drug: Divalproex sodium
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Naju National Hospital:

Primary Outcome Measures:
  • In between the two drugs at baseline MADRS score change at 8 weeks comparison. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quetiapine fumarate XR vs. Divalproex sodium treatment compared clinical outcomes in bipolar depression.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine fumarate Drug: Quetiapine fumarate
Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
Other Name: Seroquel XR, Quetiapine fumarate
Active Comparator: Divalproex sodium Drug: Divalproex sodium
Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
Other Name: Depakote XR, Divalproex sodium

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  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: NCT01587066

Locations
Korea, Republic of
Naju National Hospital
Naju, Jeollanam-do, Korea, Republic of
Sponsors and Collaborators
Bo-Hyun Yoon
Investigators
Principal Investigator: Bo-Hyun Yoon, Doctor Naju National Hospital
  More Information

No publications provided

Responsible Party: Bo-Hyun Yoon, Doctor, Naju National Hospital
ClinicalTrials.gov Identifier: NCT01587066     History of Changes
Other Study ID Numbers: D1443L00059
Study First Received: April 25, 2012
Last Updated: April 26, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014