Phase 4
N=26
A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Panic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00619892 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores — -5.3; -5.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- quetiapine XR (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores |
-5.3; -5.6 | — |
| SECONDARY Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI). |
5.0; 3.8; 6.8; 5.5; 1.3; 1.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00619892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.