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Trial record 85 of 450 for:    QUETIAPINE

Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)

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ClinicalTrials.gov Identifier: NCT00671853
Recruitment Status : Completed
First Posted : May 5, 2008
Results First Posted : October 11, 2013
Last Update Posted : December 29, 2016
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
AstraZeneca
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE May 1, 2008
First Posted Date  ICMJE May 5, 2008
Results First Submitted Date  ICMJE April 16, 2012
Results First Posted Date  ICMJE October 11, 2013
Last Update Posted Date December 29, 2016
Study Start Date  ICMJE April 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score [ Time Frame: Week 0 - Week 8 ]
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score [ Time Frame: Baseline to Study Endpoint ]
Change History Complete list of historical versions of study NCT00671853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
  • Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ]
    A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
  • Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ]
    A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.
  • Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score [ Time Frame: Week 0 - Week 8 ]
    The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
  • Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score [ Time Frame: Week 0 - Week 8 ]
    This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.
  • Change in Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: Week 0 - Week 8 ]
    The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
  • Response rate (≥ 50% improvement) on HAM-D-17 [ Time Frame: Baseline to Study Endpoint ]
  • Remission rate (≤ 7) on HAM-D-17 [ Time Frame: Baseline to Study Endpoint ]
  • Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score [ Time Frame: Baseline to Study Endpoint ]
  • Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score [ Time Frame: Baseline to Study Endpoint ]
  • Change in Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: Baseline to Study Endpoint ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)
Official Title  ICMJE Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder
Brief Summary 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.
Detailed Description

120 subjects aged 18 and up with Diagnostic and Statistical Manual -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 Institutional Review Board -approved advertising or from the clinical psychiatric infrastructure.

This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine sustained-release 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Anxiety
  • Anxiety Disorders
  • Substance Use Disorders
Intervention  ICMJE
  • Drug: Quetiapine XR
    Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
    Other Name: Seroquel XR
  • Drug: Placebo for quetiapine XR
    Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
    Other Name: Placebo for Seroquel XR
Study Arms  ICMJE
  • Experimental: 1
    Quetiapine XR
    Intervention: Drug: Quetiapine XR
  • Placebo Comparator: 2
    Placebo for quetiapine XR
    Intervention: Drug: Placebo for quetiapine XR
Publications * Gao K, Wu R, Kemp DE, Chen J, Karberg E, Conroy C, Chan P, Ren M, Serrano MB, Ganocy SJ, Calabrese JR. Efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar depression with generalized anxiety disorder and other comorbidities: a randomized, placebo-controlled trial. J Clin Psychiatry. 2014 Oct;75(10):1062-8. doi: 10.4088/JCP.13m08847.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2011)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2008)
60
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnostic and Statistical Manual-IV diagnosis of bipolar I or II disorder, and currently depressed as confirmed by the MINI-Plus at Screening.
  • Diagnostic and Statistical Manual-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 obsessive compulsive disorder.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00671853
Other Study ID Numbers  ICMJE 10-06-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keming Gao, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE
  • National Alliance for Research on Schizophrenia and Depression
  • AstraZeneca
Investigators  ICMJE
Principal Investigator: Keming Gao, PhD, MD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP