Efficacy and safety of two doses of S 90098 (1 and 2 mg/day), sublingual formulation for 8 weeks in out-patients with major depressive disorder: An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks
Phase 2
Completed
- Conditions
- Major depressive disorderMental and Behavioural DisordersRecurrent depressive disorder
- Registration Number
- ISRCTN38378163
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 264
Inclusion Criteria
1. Between 18 (or minimum legal age) and 70 years of age
2. Out-patients of both genders
3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for major depressive disorder (MDD)
Exclusion Criteria
1. Women of childbearing potential without effective contraception
2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than MDD
3. Any clinically relevant abnormality detected during the physical examination, electrocardiogram (ECG) or laboratory tests likely to interfere with the study conduct or evaluations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Rating Scale for Depression (HAM-D), assessed from baseline to week 24
- Secondary Outcome Measures
Name Time Method <br> 1. Safety<br> 2. Sleep (Leeds Sleep Evaluation Questionnaire [LSEQ])<br> 3. Long term efficacy<br> 4. Pharmacokinetic<br><br> Outcome measures will be assessed from baseline to week 24.<br>