Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder
| ISRCTN | ISRCTN75061806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75061806 |
| Protocol serial number | CL3-20098-078 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 04/07/2012
- Registration date
- 07/08/2012
- 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 Jing Ping Zhao
Scientific
Scientific
Mental Health Institute
The Second Xiangya Hospital of Central South University
No. 139, Renmin Middle Road
Changsha, Hunan, P.R.
410011
China
| Phone | +86 0731 5360921 |
|---|---|
| clinicaltrials@servier.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 12-week randomised double-blind two-arm parallel groups international multicenter study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy and safety of agomelatine (25-50 mg/day) for 12 weeks in patients with Generalized Anxiety Disorder: a randomised controlled trial |
| Study objectives | To assess the efficacy of agomelatine compared to venlafaxine after treatment in non-depressed outpatients suffering from Generalized Anxiety Disorder (GAD). |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Generalized Anxiety Disorder |
| Intervention | Therapeutic oral doses of agomelatine (25-50mg/day p.o.) and of Serotonin–norepinephrine reuptake inhibitors (SNRI), venlafaxine (p.o.), a 12 weeks study. |
| Intervention type | Other |
| Primary outcome measure(s) |
HAM-A total score expressed mainly in terms of change from baseline to last post-baseline value over the 12-week period. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 510 |
| Key inclusion criteria | 1. Asian patients aged 18 years 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder diagnosis confirmed by the M.I.N.I. questionnaire and requiring a psychotropic treatment. 3. Hamilton Anxiety Scale (HAM-A) total score >22 |
| Key exclusion criteria | 1. All types of current anxiety disorders (within 6 months prior to the selection visit) other than generalized anxiety disorder (GAD) 2. Current diagnosis of any other psychiatric disorders than GAD or severe or uncontrolled organic disease 3. Any clinically relevant abnormality detected during the physical examination, ECG, liver B ultrasound exams or laboratory tests likely to interfere with the study conduct or evaluations 4. Pregnancy or breastfeeding women |
| Date of first enrolment | 01/11/2012 |
| Date of final enrolment | 31/07/2014 |
Locations
Countries of recruitment
- China
- Hong Kong
- Malaysia
- Singapore
- Taiwan
- Thailand
Study participating centre
Mental Health Institute
Changsha, Hunan, P.R.
410011
China
410011
China
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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
09/05/2017: contact email address added.
