A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
- Conditions
- -F41F41
- Registration Number
- PER-176-08
- Lead Sponsor
- H. LUNDBECK A/S,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient can read and understand the Subject Information Sheet.
• The patient has signed the Informed Consent Form. No procedure related to the study can be performed before the patient has signed this form.
• The patient has GAD as the primary diagnosis according to the DSM-IVTR criteria (classification code 300.02).
• The patient has a total HAM-A score> 20.
• The patient has an HAM-A score> 2 in both item 1 {state of anxiety) and item 2 {tension) in the selection visit and the baseline visit.
• The patient has a total MADRS score <16 in the selection visit and in the baseline visit.
• The patient, male or female, is between 18 and 75 years old (limit values included).
• The patient, if a woman, must commit to not becoming pregnant during the study, and also use an appropriate contraceptive method (adequate contraception is an oral / systemic contraceptive method, an intrauterine device, a diaphragm in combination with spermicide, or a condom for the male member of the couple in combination with spermicide)
• The patient has one or more of the following conditions: Any current psychiatric disorder other than GAD as defined in the DSMIV-TR (evaluated with the MINI), Background or current presence of: manic or hypomanic episodes, schizophrenia or any other psychotic disorder, including major depression with psychotic characteristics, mental deficiency, organic mental disorders or mental disorders due to a general medical condition as defined in DSM-IV-TR, Any disorder related to substance use (except nicotine and caffeine) within of the previous 6 months as defined in the DSM-IV-TR, Current presence or history of clinically significant neurological disorders (including epilepsy), Neurodegenerative disorder (Alzheimer´s disease, Parkinson´s disease, multiple sclerosis, Huntington´s disease, etc.) ), Any severe axis II disorder that could compromise the study
• The patient has a significant risk of suicide according to the opinion of the investigator or has a score> 5 on item 10 (suicidal thoughts) of MADRS or has a suicide attempt within the previous 6 months.
• The patient´s current symptoms of GAD are considered by the researcher as resistant to two previous appropriate pharmacological treatments of at least 6 weeks duration.
• The patient has used or uses recent or concomitant prohibited medication (specified in Appendix II), or it is anticipated that the patient will require treatment with at least one of the concomitant medications prohibited during the study.
• The patient has received electroconvulsive therapy within 6 months prior to
• Selection.
• The patient is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy or plans to initiate such therapy during the study.
• The patient has a clinically significant unstable disease, for example, liver or kidney failure, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin or skin tissue disorders, or metabolic disorders.
• The patient has some clinically significant abnormality in vital signs.
• The patient has a history of allergy or severe drug hypersensitivity, or clinically significant lactose intolerance.
• On the basis of blood or urine samples obtained at the Selection Visit, the patient has one or more laboratory values outside the normal range that are considered by the researcher as clinically significant.
• The patient has a TSH value outside the normal range on the Selection Visit.
• The patient has a clinically significant abnormality in the ECG.
• The patient has a disease or takes medication that, at the investigator´s discretion, could interfere with safety, tolerability or efficacy evaluations.
• The patient has been treated with a medicinal product under investigation within 30 days or 5 half-lives (which implies a longer period) prior to Selection.
• The patient is pregnant or breastfeeding.
• The patient, at the discretion of the investigator, has a low probability of complying with the clinical study protocol or is not fit for any reason.
• The patient is a member of the study staff or is a direct relative of a member of the study staff.
• The patient has previously participated in this study.
• The patient has previously been exposed to Lu AA21004.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Understood by relapse either; An increase in the total HAM-A score to 15 or more, or An effect of unsatisfactory treatment (lack of efficacy) according to the investigators criteria.<br>Measure:Time to relapse<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method