Mood Disorders With Comorbid Anxiety Symptoms Clinical Trial
Official title:
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms
| Verified date | January 2012 |
| Source | Chang Gung Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chang Gung Memorial Hospital - Keelung | Keelung |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital | AstraZeneca |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hamilton Anxiety Scale(HAMA-A) total score | From baseline to Week 1, Week 4 and Week 8 | 2 months | No |
| Secondary | Item scores for Abnormal Involuntary Movement Scale(AIMS) | From baseline to Week 1, Week 4 and Week 8 | 2 months | Yes |
| Secondary | Item scores of Barnes-Akathisia Rating Scale (BARS) | From baseline to Week 1, Week 4 and Week 8 | 2 months | Yes |
| Secondary | Item scores of Simpson-Angus Scale(SAS) | From baseline to Week 1, Week 4 and Week 8 | 2 months | Yes |
| Secondary | Body Weight | From baseline to Week 1, Week 4 and Week 8 | 2 months | Yes |
| Secondary | Vital signs | From baseline to Week 1, Week 4 and Week 8 | 2 months | Yes |
| Secondary | Adverse event/Serious adverse event | From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8 | 8-9 weeks | Yes |