simple phobia
Conditions
Interventions
Trade Name: Seroquel Prolong = Seroquel XR
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Quetiapine (as Quetiapine hemifumarate)
Concentration unit: mg milligram(s)
Concentration
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. A diagnosis of simple phobia by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) 3. Females or males aged 18 to 70 years 4. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior or at enrolment and be willing to use an effective method of birth control for the duration of the study. Effective methods of birth control are defined as those which result in a low failure rate (i.e. pearl-index =65 years) yes 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 as judged by the investigator 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization 8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomization of treatment in the present study. 14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: • Unstable DM defined as enrolment 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, if the 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 Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. 16. An absolute neutrophil count (ANC) of <= 1.5 x 109 per liter 17.Exclusion criteria for magnetic resonance imaging procedures: • cardiac pacemaker or defibrillator • injured by a metallic object that was NOT removed • cochlear (ear) implants • surgery involving a metallic implant (e.g. knee replacement) • weight more than 300 lbs/136 kg (weight limit for scanner bed) • Intra-Uterine Device (IUD) • claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The current study aims to investigate the putative anxiolytic properties of quetiapine XR in patients with anxiety disorders. Therefore, in a proof-of-concept design patients with simple phobia will be selected to investigate specific anxiolytic and antipanic activity during acute anxiety. Moreover, in a combined fMRI/visual stimulus presentation paradigm activity of fear-network associated brain structures such as the amygdala will be investigated under treatment with quetiapine XR or placebo. Evaluation of acute anxiolytic properties of quetiapine in human anxiety. ;Secondary Objective: I) Evaluation of pharmacological effects of quetiapine on amygdala reactivity during phobic activation in an fMRI paradigm. II) Additionally, genetic factors potentially mediating anxiolytic properties of quetiapine will be studied. ;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed