Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms
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ClinicalTrials.gov Identifier: NCT00912535 |
Recruitment Status
:
Completed
First Posted
: June 3, 2009
Last Update Posted
: January 5, 2012
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Condition or disease | Intervention/treatment | Phase |
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Primary Anxiety Disorders Mood Disorders With Comorbid Anxiety Symptoms | Drug: Quetiapine extended release tablet Drug: Placebo | Phase 4 |
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 |
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.
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Drug: Quetiapine extended release tablet
Quetiapine extended release tablet of 50-300mg/day
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Placebo Comparator: Placebo
Placebo orally, as adjunct to the same antidepressant at the same dose.
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Drug: Placebo
Placebo orally, as adjunct to the same antidepressant at the same dose.
|
- Hamilton Anxiety Scale(HAMA-A) total score [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- Item scores for Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- Item scores of Barnes-Akathisia Rating Scale (BARS) [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- Item scores of Simpson-Angus Scale(SAS) [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- Body Weight [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- Vital signs [ Time Frame: 2 months ]From baseline to Week 1, Week 4 and Week 8
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912535
Taiwan | |
Chang Gung Memorial Hospital - Keelung | |
Keelung, Taiwan |
Principal Investigator: | Chih-Ken Chen, MD, PhD | Chang Gung Memorial Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |