40 patients with Acute Stress Disorder will be recruited within 2 years. The subjects must meet DSM- IV criteria for acute stress disorder (no acute suicidality) and will be treated with Quetiapine XR in a randomized controlled trial, comparing it to Mirtazapine.
Conditions
Interventions
Trade Name: Seroquel prolong 50 mg Retardtabletten
Product Name: Seroquel prolong 50 mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Quetiapine
Concentration uni
Sponsors
Department of Psychiatry, LMU Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects must fulfill all of the following criteria: 1. Provision of written informed consent 2. A diagnosis of “Acute Stress Disorder” by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV: 308.3) 3. Females and males aged 18-65 years 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment 5. Able to understand and comply with the requirements of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate or mirtazapine, as judged by the investigator 5. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 6. Substance or alcohol dependence (positive drugscreen or alcoholtest) at enrolment (opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment) 7. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 8. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria judged by the investigator 9. Involvement in the planning and conduct of the study 10. Previous enrolment or randomisation of treatment in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Compared to baseline and mirtazapine, quetiapine improves the key symptoms of ASD.;Secondary Objective: • Compared to mirtazapine, quetiapine reduces the risk of transition from ASD to PTSD (DSM-IV). • Compared to baseline and mirtazapine, quetiapine improves clinical global impression and psychosocial functioning. • Compared to baseline and mirtazapine, quetiapine improves quality of sleep. • Compared to mirtazapine quetiapine shortens the period of disability. ;Primary end point(s): clinical efficacy of the IMPs with regard to the key symptoms of ASD | — |
Countries
Germany
Outcome results
None listed