Quetiapine in Specific Phobia (QUISS)

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00872716
First received: March 30, 2009
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

The study hypothesis is that quetiapine XR has anxiolytic properties. The 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. Additionally, genetic factors potentially mediating anxiolytic properties of quetiapine will be studied.


Condition Intervention Phase
Specific Phobia
Drug: Quetiapine XR
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • VAS-Anxiety [ Time Frame: on study day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • State-Trait-Anxiety-Inventory (STAI) [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • Phobia specific questionnaire [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • Acute Panic Inventory (API) [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • VAS-Avoidance [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • VAS-Tension [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • VAS-Sedation [ Time Frame: on study day ] [ Designated as safety issue: No ]
  • amygdala reactivity [ Time Frame: on study day ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine XR
100 mg single-dose Quetiapine XR
Drug: Quetiapine XR
100 mg single-dose Quetiapine XR
Other Names:
  • - Seroquel XR
  • - Seroquel Prolong
  • - ATC-Code: N05A H04
Placebo Comparator: Placebo Other: Placebo
Placebo
Other Name: no other name

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • A diagnosis of simple phobia by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
  • Females or males aged 18 to 70 years
  • 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 < 1%) when used consistently and correctly such as: a hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method; an implantable contraceptive device with a failure rate less than 1% for at least 3 months prior to enrolment; vasectomized partner
  • Able to understand and comply with the requirements of the study

Exclusion Criteria:

  • Pregnancy or lactation
  • Any DSM-IV Axis I disorder not defined in the inclusion criteria
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  • Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
  • 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
  • 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
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
  • Substance or alcohol dependence at enrolment (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 criteria within 4 weeks prior to enrolment
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  • Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomization of treatment in the present study.
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  • 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.
  • An absolute neutrophil count (ANC) of <= 1.5 x 109 per liter
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872716

Locations
Germany
University Hospital Muenster, Department of Psychiatry
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
AstraZeneca
Investigators
Principal Investigator: Peter M Zwanzger, Prof Dr med University Hospital Muenster
  More Information

No publications provided

Responsible Party: Prof. Dr. med. P. Zwanzger, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00872716     History of Changes
Other Study ID Numbers: D1443L00051, EudraCT-Nr: 2008-001371-30
Study First Received: March 30, 2009
Last Updated: March 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
specific phobia
simple phobia
anxiety disorder

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014