Generalized Anxiety Disorder MedDRA version: 9.1 Level: LLT Classification code 10018075 Term: Generalised anxiety disorder
Conditions
Interventions
Product Code: LuAA21004
Pharmaceutical Form: Capsule*
Current Sponsor code: LuAA21004
Other descriptive name: 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine
Concentration unit: mg milligram(s)
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined based on the following criteria: 1. Subjects who suffer from a primary diagnosis of GAD according to DSM-IV-TR criteria (classification code 300.02). 2. Subjects with a Hamilton Anxiety Scale (HAM-A) total score =20 at Screening and Baseline. 3. Subjects with a HAM-A score =2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline. 4. Subjects with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score =16 at Screening and Baseline. 5. Male or female subjects aged between 18 years or older. 6. The subject is capable of understanding and complying with protocol requirements. 7. Male subjects, or female subjects of childbearing potential, who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women not of child bearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as greater than or equal to 48 years of age and at least 2 years since menses). [Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure Section of the protocol,Section 9.1.10.] 8. Subjects who are able to understand and sign the informed consent form prior to undergoing any study-related procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not qualify for entry into the study: 1. The subject has received any investigational compound 1.5 times the upper limits of normal (×ULN). 13. The subject has a serum creatinine of >1.5 ×ULN. 14. The subject has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those subjects with basal cell or stage I squamous cell carcinoma of the skin. 15. The subject has clinically significant abnormal vital signs as determined by the investigator. 16. The subject has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant. 17. The subject has thyroid stimulating hormone (TSH) value outside the normal range at Screeni
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 5 mg Lu AA21004 QD versus placebo after 8 weeks of treatment in subjects with GAD.;Secondary Objective: • To evaluate the efficacy of 5 mg Lu AA21004 QD compared with placebo during the 8-week, double-blind treatment. • To evaluate the proportion of subjects who respond to Lu AA21004 treatment compared with placebo after 8 weeks of treatment. • To evaluate the proportion of subjects who are in remission after 8 weeks of treatment with Lu AA21004 compared with placebo. • To evaluate the effect of Lu AA21004 on global clinician-rated assessments. • To evaluate the effect of Lu AA21004 on patient-rated assessments of anxiety, quality of life, and disability. • To evaluate the effects of Lu AA21004 on health care resource utilization. • To evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835. • To evaluate the safety and tolerability of 5 mg Lu AA21004 QD compared with placebo during the course of treatment. Exploratory Objective: • To assess the treatment effect (Lu AA21004 or placebo) on suicidal ideation and behavior.;Primary end point(s): The primary endpoint for this study is the least squares (LS) mean change from Baseline in the 14-item HAM-A total score after 8 weeks of treatment. Secondary Endpoints Efficacy: Secondary efficacy endpoints for this study are: • LS mean change from Baseline in HAM-A total score at each week assessed. • Response rates at Week 8, with response defined as a =50% decrease in the HAM-A total score from Baseline. • Remission rates at Week 8, with remission defined as a HAM-A total score =7. • LS mean change from Baseline in CGI-I, CGI-S, and Hospital Anxiety and Depression Scale (HAD) at all study visits where rated. Pharmacoeconomic Measures: The following will be evaluated: • Sheehan Disability Scale (SDS). • Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36®). • Health care resource utilization as assessed by the Health E | — |
Countries
Estonia, Germany, Latvia, Lithuania, Poland, United Kingdom
Outcome results
None listed