A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Condition: Panic Disorder
MeSH terms: Panic Disorder
Intervention: quetiapine XR; placebo
Intervention description: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.; Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: SSRI Resistant; Seroquel SR; Seroquel XR; Panic Disorder; Comorbid Panic Disorder; Quetiapine SR; Quetiapine XR

Summary:

      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.
    

Eligibility criteria:

        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.