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
| ISRCTN | ISRCTN38378163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38378163 |
| EudraCT/CTIS number | 2007-003312-65 |
| Secondary identifying numbers | CL2-90098-005 |
- Submission date
- 27/03/2008
- Registration date
- 24/04/2008
- Last edited
- 20/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Frédéric Rouillon
Scientific
Scientific
Centre Hospitalier de Sainte Anne CMME
100 rue de la santé
PARIS cedex 14
75674
France
| F.ROUILLON@ch-sainte-anne.fr |
Study information
| Study design | Randomised, double-blind, parallel group, placebo-controlled, multicentre, phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study objectives | To assess the antidepressant efficacy of S 90098 in outpatients suffering from major depressive disorder (MDD). |
| Ethics approval(s) | First ethics committee approval in France on 25/01/2008 (ref: 87-07, CPP Ile de France VI). |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Eight-week randomised treatment period with agomelatine orodispersible 1 or 2 mg/day versus placebo followed by an extension double-blind period for 16 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | S 90098 |
| Primary outcome measure | Hamilton Rating Scale for Depression (HAM-D), assessed from baseline to week 24 |
| Secondary outcome measures | 1. Safety 2. Sleep (Leeds Sleep Evaluation Questionnaire [LSEQ]) 3. Long term efficacy 4. Pharmacokinetic Outcome measures will be assessed from baseline to week 24. |
| Overall study start date | 25/02/2008 |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 264 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 25/02/2008 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Czech Republic
- Estonia
- Finland
- France
- Lithuania
Study participating centre
Centre Hospitalier de Sainte Anne CMME
PARIS cedex 14
75674
France
75674
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | 20/04/2020 | No | No |
Editorial Notes
20/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
04/12/2017: Results summary added.
