The effects of combination treatment for panic

Phase 1

• Conditions: DSM-IV Panic disorder; MedDRA version: 14.1 Level: HLT Classification code 10068300 Term: Panic attacks and disorders System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2012-003191-39-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-03
• Study Completion: 2017-09-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

• Diagnosed with DSM-IV panic disorder
• At least moderate avoidance of agoraphobic situations (”yes” response to at least 3 situations listed under (2) Avoidance – Do you avoid or feel very uncomfortable in …” in the Structured Panic Assessment Interview (Clark, 1989))
• Participant is willing and able to give informed consent for participation in the study and to comply with all study requirements.
• Male or Female, aged 18 years or above.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

• Female participant who is pregnant, breast-feeding, or planning pregnancy
• CNS-active medication during the last 6 weeks
• Exposure-based psychological treatment for panic disorder and agoraphobia during the last 3 months
• Lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
• Lifetime history of epilepsy or other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
• Insufficient English skills
• Patient not able to refrain from benzodiazepines 48hrs before treatment and testing sessions
• Any other significant disease or disorder or circumstance, which, in the opinion of the investigator, may either put the participant at risk or may influence the results of the study or the participant’s ability to participate in the study.

Participants with contraindication to MRI scanning (e.g. pacemaker, metal implant, left-handedness) will be included in the study but will not undergo the MRI scan study component.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified