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

NCT00912535 | Completed Phase 4

• 1 other identifier: D1443C00026
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms

Keywords

Primary Anxiety Disorders; Mood Disorders with Comorbid Anxiety Symptoms

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Scale(HAMA-A) total score

  From baseline to Week 1, Week 4 and Week 8

  2 months

Secondary Outcomes (6)

• Item scores for Abnormal Involuntary Movement Scale(AIMS)

  2 months

• Item scores of Barnes-Akathisia Rating Scale (BARS)

  2 months

• Item scores of Simpson-Angus Scale(SAS)

  2 months

• Body Weight

  2 months

• Vital signs

  2 months

Study Arms (2)

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.

Drug: Quetiapine extended release tablet

Placebo

PLACEBO COMPARATOR

Placebo orally, as adjunct to the same antidepressant at the same dose.

Drug: Placebo

Interventions

Quetiapine extended release tablet DRUG

Quetiapine extended release tablet of 50-300mg/day

Quetiapine extended release tablet

Placebo DRUG

Placebo orally, as adjunct to the same antidepressant at the same dose.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• 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:

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Chang Gung Memorial Hospital - Keelung

Keelung, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 23020711 DERIVED

Study Officials

• Chih-Ken Chen, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 24, 2009
• First Posted: June 3, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

TW (1)