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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Chih-Ken Chen, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00912535
First received: May 24, 2009
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Primary Anxiety Disorders
Mood Disorders With Comorbid Anxiety Symptoms
Drug: Quetiapine extended release tablet
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Hamilton Anxiety Scale(HAMA-A) total score [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    From baseline to Week 1, Week 4 and Week 8


Secondary Outcome Measures:
  • Item scores for Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    From baseline to Week 1, Week 4 and Week 8

  • Item scores of Barnes-Akathisia Rating Scale (BARS) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    From baseline to Week 1, Week 4 and Week 8

  • Item scores of Simpson-Angus Scale(SAS) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    From baseline to Week 1, Week 4 and Week 8

  • Body Weight [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    From baseline to Week 1, Week 4 and Week 8

  • Vital signs [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    From baseline to Week 1, Week 4 and Week 8

  • Adverse event/Serious adverse event [ Time Frame: 8-9 weeks ] [ Designated as safety issue: Yes ]
    From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8


Enrollment: 39
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Quetiapine extended release tablet
Quetiapine extended release tablet of 50-300mg/day
Placebo Comparator: Placebo
Placebo orally, as adjunct to the same antidepressant at the same dose.
Drug: Placebo
Placebo orally, as adjunct to the same antidepressant at the same dose.

  Eligibility

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

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
  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: NCT00912535

Locations
Taiwan
Chang Gung Memorial Hospital - Keelung
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
AstraZeneca
Investigators
Principal Investigator: Chih-Ken Chen, MD, PhD Chang Gung Memorial Hospital
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chih-Ken Chen, Attending Physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00912535     History of Changes
Other Study ID Numbers: D1443C00026
Study First Received: May 24, 2009
Last Updated: January 3, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Primary Anxiety Disorders
Mood Disorders with Comorbid Anxiety Symptoms

Additional relevant MeSH terms:
Anxiety Disorders
Mood Disorders
Mental Disorders
Antidepressive Agents
Quetiapine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014