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

Phase 4

Completed

• Conditions: Mood Disorders With Comorbid Anxiety Symptoms; Primary Anxiety Disorders
• Interventions: Drug: Quetiapine extended release tablet; Drug: Placebo

• Registration Number: NCT00912535
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-24
• Study First Submitted QC: 2009-05-31
• Study First Posted: 2009-06-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine extended release tablet	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.
Placebo	Placebo	Placebo orally, as adjunct to the same antidepressant at the same dose.

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale(HAMA-A) total score	2 months	From baseline to Week 1, Week 4 and Week 8

Secondary Outcome Measures

Name	Time	Method
Item scores for Abnormal Involuntary Movement Scale(AIMS)	2 months	From baseline to Week 1, Week 4 and Week 8
Item scores of Simpson-Angus Scale(SAS)	2 months	From baseline to Week 1, Week 4 and Week 8
Item scores of Barnes-Akathisia Rating Scale (BARS)	2 months	From baseline to Week 1, Week 4 and Week 8
Body Weight	2 months	From baseline to Week 1, Week 4 and Week 8
Vital signs	2 months	From baseline to Week 1, Week 4 and Week 8
Adverse event/Serious adverse event	8-9 weeks	From the time Informed Consent has been obtained to Week 1, Week 4 and Week 8

Trial Locations

Locations (1)

Chang Gung Memorial Hospital - Keelung; 🇨🇳 Keelung, Taiwan