DSM panic disorder MedDRA version: 18.1 Level: HLT Classification code 10068300 Term: Panic attacks and disorders System Organ Class: 100000004873
Conditions
Interventions
Product Name: losartan
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: losartan
CAS Number: 114798-26-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *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 *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) 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: *Female participant who is pregnant or breast-feeding *CNS-active medication during the last 6 weeks *Current blood pressure or other heart medication (especially aliskiren or beta blockers) *Intravascular fluid depletion *Impaired liver or kidney function *Lifetime history of epilepsy or other neurological disease, systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary 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. *Lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder *Insufficient English skills *Participated in another study involving certain medication during the last 6 weeks *Exposure-based psychological treatment for panic disorder and agoraphobia during the last 3 months *Patient not able to refrain from benzodiazepines 48hrs before treatment and testing sessions Participants with MRI contraindications (e.g. pacemaker, metal implant, left-handedness) will be included in the study but will not undergo the MRI scan study component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Threat bias on the day after treatment (reaction time scores derived from computerised behavioural reaction tasks);Timepoint(s) of evaluation of this end point: day after treatment (visit 3);Main Objective: To investigate whether the combination of a single-session of cognitive-behaviour therapy (CBT) with the antihypertensive drug (compared to placebo) leads to greater reduction in threat bias on the day after treatment.;Secondary Objective: *To investigate whether such an increased change in threat bias is underpinned by stronger alterations in responsivity in the fear circuit of the brain on the day after treatment; *To investigate whether CBT plus losartan (versus placebo) leads to greater symptom improvement on the day after treatment and at follow-ups; *To investigate whether CBT plus losartan (versus placebo) leads to greater stress resistance on the day after treatment and at follow-ups *To investigate whether threat bias measured before treatment can predict treatment success with placebo versus losartan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Responsivity in the fear circuit of the brain (fMRI); *Self-report (BDI, STAIT. STAIS, ACQ, BSQ, MI, PAS) and clinician-rated (PDSSC, CGI) symptom questionnaire scores; *Anxiety ratings during stress test (VAS); *Threat bias measured with EEG ;Timepoint(s) of evaluation of this end point: *fMRI: day after treatment (visit 3) *symptom questionnaire scores: before treatment, day after treatment, 1- and 6-month follow-up (visits 2, 3, 4, 5) *stress test: before treatment, day after treatment, 1- and 6-month follow-up (visits 2, 3, 4, 5) *EEG: before teratment (visit 2) | — |
Countries
United Kingdom
Contacts
Public ContactDr Andrea Reinecke
University of Oxford
Outcome results
None listed