A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose StudyComparing the Efficacy and Safety of a Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety DisorderMedDRA version: 9.1Level: LLTClassification code 10018075Term: Generalised anxiety disorder
- Registration Number
- EUCTR2008-001766-90-EE
- Lead Sponsor
- Takeda Global Research & Development Centre (Europe) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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 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.]
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
Subjects who meet any of the following criteria will not qualify for entry into the study:
1. The subject has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
2. The subject has received Lu AA21004 in a previous clinical study or as a therapeutic agent.
3. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
4. The subject has 1 or more of the following:
a) Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
b) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
c) Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (Subject must have a negative urine drug screen prior to Baseline).
d) Presence or history of a clinically significant neurological disorder (including epilepsy).
e) Neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington disease, etc).
f) Any Axis II disorder that might compromise the study.
5. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study. (Please refer to Section 7.3 Excluded Medications.)
6. If female, the subject is pregnant or lactating.
7. The subject has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
8. The subject has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors (SSRIs) and/or serotonin norepinephrine reuptake inhibitors (SNRIs).
9. The subject has received electroconvulsive therapy within 6 months prior to Screening.
10. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
11. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
12. The subject has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >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 value outside the normal range at the Screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method