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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms

Treatments: Drug: Quetiapine extended release tablet; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00912535

D1443C00026

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Quetiapine extended release tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Quetiapine extended release tablet

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo