Early effect of agomelatine on general interest in outpatients suffering major depressive disorder
| ISRCTN | ISRCTN28327843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28327843 |
| Protocol serial number | CL3-20098-083 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 24/03/2011
- Registration date
- 04/05/2011
- Last edited
- 18/04/2018
- 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 Tudor Udristoiu
Scientific
Scientific
Spitalul Clinic de Neuropsihiatrie Craiova
Clinica 1 Psihiatrie
Aleea Potelu No 24
Craiova
200317
Romania
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel group randomised double-blind multicentre study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Early effect of agomelatine on general interest in outpatients suffering major depressive disorder: a parallel group, randomised, double-blind, multicentre study |
| Study objectives | To assess the early effect of agomelatine on general interest in outpatients suffering from major depressive disorder Please note tht as of 26/11/2012, the anticipated end date for this trial was updated from 30/09/2012 to 30/03/2013. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Therapeutic oral doses of agomelatine and therapeutic oral doses of selective serotonin reuptake inhibitors (SSRI) for 12 weeks, a randomised double-blind period |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
General interest score obtained from the Visual Analogue Scale (VAS) reflecting the item 13 of the QIDS-SR 16 scale |
| Key secondary outcome measure(s) |
To provide additional efficacy, safety and tolerability data on agomelatine |
| Completion date | 30/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Male or female outpatients 2. Aged between 18 and 65 years (inclusive) at the time of selection 3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) criteria for current major depressive episode (MDE) < = 12months, of moderate to severe intensity 4. Major depressive episode diagnosis documented using the brief structured Mini-International Neuropsychiatric Interview (M.I.N.I.) 5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) item 13 (General interest) > = 2 6. Hamilton Rating Scale for Depression (HAM-D-17) total score > = 22 7. Clinical Global Impression - Severity (CGI-S) (Severity of illness) > = 4 (moderately to severely ill) 8. Requiring an antidepressant treatment |
| Key exclusion criteria | 1. Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features,catatonic features or with duration <4 weeks 2. All types of depression other than MDD, according to DSM-IV-TR criteria 3. Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previoussuicide attempts, quality of social and familial support 4. Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception 5. Hepatic impairment 6. Severe renal insufficiency |
| Date of first enrolment | 23/05/2011 |
| Date of final enrolment | 30/03/2013 |
Locations
Countries of recruitment
- Romania
Study participating centre
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova
200317
Romania
200317
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
Editorial Notes
18/04/2018: Internal review.
28/03/2018: Publication plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
19/12/2017: results summary added.
