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Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
This study is currently recruiting participants.
Verified by University Hospital Case Medical Center, July 2009
First Received: May 1, 2008   Last Updated: July 21, 2009   History of Changes
Sponsors and Collaborators: University Hospital Case Medical Center
National Alliance for Research on Schizophrenia and Depression
Information provided by: University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00671853
  Purpose

The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.


Condition Intervention Phase
Bipolar Disorder
Anxiety
Anxiety Disorders
Substance Use Disorders
Drug: Quetiapine XR
Drug: Placebo for quetiapine XR
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title: Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (≥ 50% improvement) on HAM-D-17 [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
  • Remission rate (≤ 7) on HAM-D-17 [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
  • Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score [ Time Frame: Baseline to Study Endpoint ] [ Designated as safety issue: No ]
  • Change in Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Quetiapine XR
Drug: Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
2: Placebo Comparator
Placebo for quetiapine XR
Drug: Placebo for quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

Detailed Description:

120 subjects aged 18 and up with DSM-IV Generalized Anxiety Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized. Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs without SUD. Potential participants will be recruited by means of IRB-approved advertising or from the clinical psychiatric infrastructure.

This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine SR monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. Subjects will be assessed weekly for mood changes and side effects.

  Eligibility

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

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar I or II disorder, and currently depressed as confirmed by the MINI-Plus at Screening.
  • DSM-IV diagnosis of lifetime GAD;
  • Hamilton Depression Rating Scale -17 items total score ≥ 18;
  • Hamilton Anxiety Rating Scale total score ≥ 18;
  • Be male or female at least 18 year old and not older than 65.

Exclusion Criteria:

  • Pregnancy or breast feeding.
  • Severe medical or neurological problems.
  • Severe personality disorder.
  • Currently suicidal risk judged by physician.
  • Known history of intolerance or hypersensitivity to any of the medications involved in the study.
  • Treatment with quetiapine at any dose in the 6 months prior to randomization.
  • Known lack of response to quetiapine in a dosage of at least 50 mg for 4 weeks at any time, as judged by the investigator.
  • Dependence on opiate, phencyclidine (PCP), and/or barbiturate.
  • Acute mania as determined by a score > 12 on the Young Mania Rating Scale at baseline.
  • Concurrent OCD.
  • Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
  • Use of any of the following cytochrome P450 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
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  • Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomisation of treatment in the present study.
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  • A patient with diabetes mellitus (DM) fulfilling one of the following criteria: a. Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) .8.5% b. Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks c. Not under physician care for DM d. Physician responsible for patient's DM care has not indicated that the patient's DM is controlled f. Physician responsible for patient's DM care has not approved the patient's participation in the study g. Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization h. 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 patient with DM 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671853

Contacts
Contact: Liz Fein, MA 216-844-2863 Elizabeth.Fein@UHhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Liz Fein, MA     216-844-2863     Elizabeth.Fein@UHhospitals.org    
Principal Investigator: Keming Gao, PhD, MD            
Sponsors and Collaborators
University Hospital Case Medical Center
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Keming Gao, PhD, MD University Hospitals Case Medical Center
  More Information

No publications provided

Responsible Party: University Hospital Case Medical Center ( Keming Gao, Ph.D., M.D. )
Study ID Numbers: 10-06-19
Study First Received: May 1, 2008
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00671853     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital Case Medical Center:
Bipolar Disorder
Anxiety
Anxiety Disorders
Substance Use Disorders

Study placed in the following topic categories:
Depression
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Depressive Disorder
Antipsychotic Agents
Affective Disorders, Psychotic
Quetiapine
Anxiety Disorders
Mental Disorders
Substance-Related Disorders
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Affective Disorders, Psychotic
Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009