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.

Study Overview

• Status: Completed
• Conditions: Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms
• Intervention / Treatment: Drug: Quetiapine extended release tablet; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan
    • Chang Gung Memorial Hospital - Keelung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Scale(HAMA-A) total score	From baseline to Week 1, Week 4 and Week 8	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Item scores for Abnormal Involuntary Movement Scale(AIMS)	From baseline to Week 1, Week 4 and Week 8	2 months
Item scores of Barnes-Akathisia Rating Scale (BARS)	From baseline to Week 1, Week 4 and Week 8	2 months
Item scores of Simpson-Angus Scale(SAS)	From baseline to Week 1, Week 4 and Week 8	2 months
Body Weight	From baseline to Week 1, Week 4 and Week 8	2 months
Vital signs	From baseline to Week 1, Week 4 and Week 8	2 months
Adverse event/Serious adverse event	From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8	8-9 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Chih-Ken Chen, MD, PhD, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: May 24, 2009
• First Submitted That Met QC Criteria: May 31, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Primary Anxiety Disorders; Mood Disorders with Comorbid Anxiety Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Mood Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1443C00026