Long-term efficacy and safety of agomelatine in non-depressed out-patients with generalized anxiety disorder. A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)
| ISRCTN | ISRCTN38094599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38094599 |
| Clinical Trials Information System (CTIS) | 2006-005674-47 |
| Protocol serial number | CL3-20098-050 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 24/09/2007
- Registration date
- 26/03/2008
- 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 Istvan Bitter
Scientific
Scientific
Department of Psychiatry and Psychotherapy
Semmelweis University
Balassa u.6.
Budapest
1083
Hungary
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group placebo-controlled multi-centre phase III study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Long-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day). |
| Study objectives | To assess the efficacy of agomelatine in the prevention of relapse in non-depressed out-patients with Generalized Anxiety Disorder (GAD) after an initial response to agomelatine. |
| Ethics approval(s) | First ethics committee approval in Estonia (Tallin Medical Research Ethics Committee) on 16/08/2007 (ref: 1121) |
| Health condition(s) or problem(s) studied | Generalized anxiety disorder |
| Intervention | Agomelatine versus placebo |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
Time to relapse |
| Key secondary outcome measure(s) |
1. Evaluation of anxiety (Hamilton rating scale for anxiety [HAM-A]) |
| Completion date | 15/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 370 |
| Key inclusion criteria | 1. Aged over 18 years 2. Out-patients of both genders 3. Fulfilling the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for GAD |
| Key exclusion criteria | 1. Women of childbearing potential without effective contraception 2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD 3. Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations |
| Date of first enrolment | 15/10/2007 |
| Date of final enrolment | 15/03/2010 |
Locations
Countries of recruitment
- Canada
- Denmark
- Estonia
- Finland
- Hungary
- Sweden
Study participating centre
Department of Psychiatry and Psychotherapy
Budapest
1083
Hungary
1083
Hungary
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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No | |
| 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 and dissemination plan and IPD sharing statement updated.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.
