Phase IV to Evaluate the Safety of Self-administered ADASUVEĀ® in Agitated Patients Outside the Hoā¦ (NCT02525991) | Clinical Trial Compass
CompletedPhase 4
Phase IV to Evaluate the Safety of Self-administered ADASUVEĀ® in Agitated Patients Outside the Hospital Setting
Spain323 participantsStarted 2016-09-08
Plain-language summary
Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVEĀ® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVEĀ® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVEĀ® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Male and female patients between the ages of 18-65 years, inclusive
ā. Patients (or legal representative) willing and able to provide written Informed Consent Form.
ā. Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders- IV, Diagnostic and Statistical Manual of Mental Disorders- V or International Code of Disease criteria.
ā. Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting.
ā. Previously treated with ADASUVEĀ® with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
ā. Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema).
ā. Requirement of family or other caregiver support at study investigator criteria (defined as a patient's relative or caregiver (male or female) ā¤ 80 year old, who spend ā„ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures).
What they're measuring
1
Serious adverse events and adverse events of special interest ( respiratory)