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Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms

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ClinicalTrials.gov Identifier: NCT00912535
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Chih-Ken Chen, Chang Gung Memorial Hospital

May 24, 2009
June 3, 2009
January 5, 2012
May 2009
July 2010   (Final data collection date for primary outcome measure)
Hamilton Anxiety Scale(HAMA-A) total score [ Time Frame: 2 months ]
From baseline to Week 1, Week 4 and Week 8
Hamilton Anxiety Scale(HAMA-A) total score [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
Complete list of historical versions of study NCT00912535 on ClinicalTrials.gov Archive Site
  • Item scores for Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 months ]
    From baseline to Week 1, Week 4 and Week 8
  • Item scores of Barnes-Akathisia Rating Scale (BARS) [ Time Frame: 2 months ]
    From baseline to Week 1, Week 4 and Week 8
  • Item scores of Simpson-Angus Scale(SAS) [ Time Frame: 2 months ]
    From baseline to Week 1, Week 4 and Week 8
  • Body Weight [ Time Frame: 2 months ]
    From baseline to Week 1, Week 4 and Week 8
  • Vital signs [ Time Frame: 2 months ]
    From baseline to Week 1, Week 4 and Week 8
  • Adverse event/Serious adverse event [ Time Frame: 8-9 weeks ]
    From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8
  • Item scores for Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
  • Item scores of Barnes-Akathisia Rating Scale (BARS) [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
  • Item scores of Simpson-Angus Scale(SAS) [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
  • Body Weight [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
  • Vital signs [ Time Frame: From baseline to Week 1, Week 4 and Week 8 ]
  • Adverse event/Serious adverse event [ Time Frame: From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8 ]
Not Provided
Not Provided
 
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms
The objectives of this study are to evaluate the efficacy and safety of quetiapine extended release tablet versus placebo as adjunct to selective serotonin reuptake inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety symptoms.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Primary Anxiety Disorders
  • Mood Disorders With Comorbid Anxiety Symptoms
  • Drug: Quetiapine extended release tablet
    Quetiapine extended release tablet of 50-300mg/day
  • Drug: Placebo
    Placebo orally, as adjunct to the same antidepressant at the same dose.
  • Active Comparator: Quetiapine extended release tablet
    Quetiapine orally at a flexible dose fo 50-300mg/day according to the judgment by the investigator for 8 weeks, as adjunct to the same antidepressant at the same dose.
    Intervention: Drug: Quetiapine extended release tablet
  • Placebo Comparator: Placebo
    Placebo orally, as adjunct to the same antidepressant at the same dose.
    Intervention: Drug: Placebo
Chen YC, Chen CK, Wang LJ. Quetiapine fumarate augmentation for patients with a primary anxiety disorder or a mood disorder: a pilot study. BMC Psychiatry. 2012 Sep 29;12:162. doi: 10.1186/1471-244X-12-162.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
60
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of written informed consent
  • A diagnosis of primary anxiety disorder or mood disorder with co-morbid anxiety symptoms by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
  • A 14-item Hamilton Anxiety Scale (HAM-A)>= 14
  • Subject have received single antidepressant at a therapeutic dose for at least 6 weeks
  • Male or female aged 18-65 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 and sign informed consent

Exclusion Criteria:

  • Pregnancy or lactation
  • Any DSM-IV Axis I disorder not defined in the inclusion criteria.
  • Receiving any anti-psychotic 7 days prior to entering the study
  • Patients who, in the opinion of the investigator, post an imminent risk of suicide or a danger to self or others
  • Known intolerance or lack of response to quetiapine fumarate, 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, erythromycin, 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 randomization
  • 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 4 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 failures, angina pectoris, hypertension) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • Previous enrollment or randomization of treatment in the present study
  • Participation in another drug trial within 4 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 enrollment glycosylated hemoglobin(HbA1c)> 8.5%
    • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
    • Not under physician care for DM
    • 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 randomization. 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
  • An absolute neutrophil count (ANC) of <= 1.5x10(9) per liter
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00912535
D1443C00026
Not Provided
Not Provided
Not Provided
Chih-Ken Chen, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
AstraZeneca
Principal Investigator: Chih-Ken Chen, MD, PhD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
January 2012

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