A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients

Official Title: “An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder”

The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.

Intervention(s) in this Clinical Trial

• Drug: quetiapine SR
  • Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
• Drug: placebo
  • Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Decrease in mean total Panic Disorder Symptom Scale (PDSS) scores
  • Time Frame: First 1 to 3 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Decrease in scores in measurements of depressive (Hamilton Depression Rating Scale), generalized anxiety symptoms (Hamilton Anxiety Rating Scale) and sleep quality (Pittsburgh Sleep Quality Index).
  • Time Frame: End of 8 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Provision of written informed consent
• Diagnosis of Panic Disorder by DSM-IV TR and confirmed by MINI plus interview
• Females and males ages 18-65 years old
• Female patients of childbearing potential must by 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
• Have a CGI illness severity score = or > 4
• Patients with comorbid major depression, dysthymia or other anxiety problems are eligible to participate as well.

Exclusion criteria:

• Pregnancy or lactation
• Any DSM-IV TR Axis I disorder not mentioned in the inclusion requirements
• Suicidal or danger to self or others
• Known intolerance to quetiapine fumarate or intolerance to SSRI therapy
• 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 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
• TR 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. 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 a diagnosis of Type I or Type II Diabetes Mellitus (DM)
• An absolute neutrophil count (ANC) of 1.5 x 109 per liter
• A lifetime history of a pre-existing CNS/neurological disorder e.g. epilepsy, TBI, brain tumor
• Patient with severe personality disorders
• Patients who have started a new course of psychotherapy (CBT, supportive, insight-oriented) within 1 month of the screening visit
• Patients unwilling to refrain from participation in psychotherapy during the 9-week period of the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Indiana University Other

Overall Clinical Trial Officials and Contacts

Andrew W. Goddard, M.D. Principal Investigator Indiana University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619892

Study ID Number: 0703-22

ClinicalTrials.gov Identifier: NCT00619892

Health Authority: United States: Institutional Review Board