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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms	Drug: Quetiapine extended release tablet; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms
Study Start Date :	May 2009
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	July 2010

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Hamilton Anxiety Scale(HAMA-A) total score [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8

Secondary Outcome Measures :

1. Item scores for Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8
2. Item scores of Barnes-Akathisia Rating Scale (BARS) [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8
3. Item scores of Simpson-Angus Scale(SAS) [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8
4. Body Weight [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8
5. Vital signs [ Time Frame: 2 months ]
   From baseline to Week 1, Week 4 and Week 8
6. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Chih-Ken Chen, Attending Physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00912535 History of Changes
Other Study ID Numbers:	D1443C00026
First Posted:	June 3, 2009
Last Update Posted:	January 5, 2012
Last Verified:	January 2012

Keywords provided by Chih-Ken Chen, Chang Gung Memorial Hospital:

Primary Anxiety Disorders; Mood Disorders with Comorbid Anxiety Symptoms

Additional relevant MeSH terms:

Anxiety Disorders; Disease; Mood Disorders; Pathologic Processes; Mental Disorders; Antidepressive Agents	Quetiapine Fumarate; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs