generalised anxiety disorder MedDRA version: 8.1 Level: LLT Classification code 10017571 Term: GAD
Conditions
Interventions
Product Code: ABIO 08/01
Pharmaceutical Form: Tablet
Current Sponsor code: ABIO 08/01
Other descriptive name: BTG 1640
Concentration unit: mg milligram(s)
Concentration type: range
Concentration numbe
Sponsors
Abiogen Pharma S.p.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Sex: males Age: 18-65 y old Anxiety: GAD newly diagnosed according to the DSM IV F41.1 codification Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study Informed Consent: signed written informed consent prior to inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study Diseases: relevant history of other psychiatric, neurological, renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological or endocrine diseases, that may interfere with the aim of the study Concomitant therapy: any other psychopharmacological agents Investigative drug trials: participation in the evaluation of any drug within 1 month prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical improvement of a GAD measured by means of a decrease of CGI score assessed at the end of the 8-week treatment vs. baseline score;Secondary Objective: - Clinical improvement of a GAD measured by means of a decrease of HAM-A observer rating scale, Zung SAS and STAI self-rating scale scores assessed at the end of the 8-week treatment vs. baseline score - Clinical improvement of depression measured by means of a decrease of HAM-D observer rating scale and Zung SDA self-rating scale scores assessed at the end of the 8-week treatment vs. baseline score - Safety and tolerability of the treatment assessed by means of AEs and clinical laboratory assays - Evaluation of effects on CNS by means of EEG/ERP topography and tomography - Evaluation of hypnotic effects by means of all-night polysomnography - Evaluation of subjective sleep and awakening quality and thymopsychic state by means of SSA, Von Zerssen and VAS scores and psychometry.;Primary end point(s): Clinical improvement of a GAD measured by means of a decrease of CGI score assessed at the end of the 8-week treatment vs. baseline score | — |
Countries
Austria
Outcome results
None listed