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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine extended release tablet | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | Placebo orally, as adjunct to the same antidepressant at the same dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine extended release tablet | Drug | Quetiapine extended release tablet of 50-300mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Scale(HAMA-A) total score | From baseline to Week 1, Week 4 and Week 8 | 2 months |
| 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 |
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Inclusion Criteria:
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:
An absolute neutrophil count (ANC) of <= 1.5x10(9) per liter
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Ken Chen, MD, PhD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital - Keelung | Keelung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23020711 | Derived | 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. |
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| Placebo | Drug | Placebo orally, as adjunct to the same antidepressant at the same dose. |
|
| 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 |