Initiation of agomelatine after antidepressant treatment in outpatients suffering major depressive disorder
| ISRCTN | ISRCTN97599615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97599615 |
| EudraCT/CTIS number | 2010-019556-44 |
| Secondary identifying numbers | CL3-20098-073 |
- Submission date
- 16/07/2010
- Registration date
- 10/09/2010
- Last edited
- 21/04/2020
- 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 Michel Lejoyeux
Scientific
Scientific
Hôpital Bichat - Claude Bernard
46 rue Henri Huchard
Paris
75018
France
Study information
| Study design | Randomised double then single-blind controlled parallel group international multicentre safety study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period. |
| Study objectives | To compare three different ways to initiate agomelatine after antidepressant treatment. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Major depressive disorder |
| Intervention | Therapeutic oral doses of agomelatine and therapeutic oral doses of previous antidepressant treatment. Run in period, 3-week randomised period then 5-week extension period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure | Total number of discontinuation emergent symptoms according to the Discontinuation-Emergent Signs and Symptoms check-list evaluated at week 0, week 1, week 2 and week 3. |
| Secondary outcome measures | 1. Adverse events (evaluated at all visits) 2. Haematology and biochemistry parameters (at week 0 and week 3 - and week 8 for liver function only) 3. Vital signs (blood pressure and heart rate) 4. Body weight, body mass index (BMI) (ASSE, week 0, week 3 and week 8) |
| Overall study start date | 01/11/2010 |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 316 |
| Key inclusion criteria | 1. Aged between 18 and 65 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR) criteria for major depressive episode of moderate or severe intensity 3. Diagnosis documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI) 4. Clinical Global Impression scale 5. Requiring a change in antidepressant treatment due to an insufficient treatment efficacy associated or not with poor acceptability |
| Key exclusion criteria | 1. "High suicidality" according to MINI 5.0.0. 2. Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion 3. Hepatic impairment |
| Date of first enrolment | 01/11/2010 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Belgium
- Brazil
- France
- Germany
- Hungary
- Italy
- Portugal
- Spain
Study participating centre
Hôpital Bichat - Claude Bernard
Paris
75018
France
75018
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 | Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. |
| 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 | 21/04/2020 | No | No |
Editorial Notes
21/04/2020: 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 plan and IPD sharing statement were updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.
