Status:
COMPLETED
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Primary Anxiety Disorders
Mood Disorders With Comorbid Anxiety Symptoms
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00912535
Start Date
May 1 2009
End Date
July 1 2010
Last Update
January 5 2012
Active Locations (1)
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1
Chang Gung Memorial Hospital - Keelung
Keelung, Taiwan