Efficacy and safety of agomelatine for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder
| ISRCTN | ISRCTN03554974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03554974 |
| EudraCT/CTIS number | 2009-013789-17 |
| Secondary identifying numbers | CL3-20098-071 |
- Submission date
- 02/06/2010
- Registration date
- 05/07/2010
- 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 Antti Ahokas
Scientific
Scientific
Mehilainen Clinic
Runeberginkatu 47 A
Helsinki
00260
Finland
Study information
| Study design | 12-week randomised double blind placebo controlled with escitalopram as validator 3-arm parallel group international multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalised Anxiety Disorder |
| Study objectives | To confirm the superiority of agomelatine compared to placebo in treatment of non-depressed out-patients suffering from Generalised Anxiety Disorder (GAD). |
| Ethics approval(s) | Committee I. of Ethics in Clinical Trials (Comite I. de Etica para Ensayos en Farmacologia Clinica) of the University of Medicine at Buenos Aires approved on 26/11/2009 |
| Health condition(s) or problem(s) studied | Generalised Anxiety Disorder |
| Intervention | Agomelatine 25 or 50 mg versus placebo and escitalopram 10 or 20 mg |
| Intervention type | Other |
| Primary outcome measure | Hamilton Anxiety (HAM-A) total score, in the W0-W12 period (baseline to 12 weeks) |
| Secondary outcome measures | 1. Hamilton Anxiety (HAM-A) items from baseline to W12 (week 12) 2. Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I) scores from baseline to W13 3. Hospital Anxiety Depression (HAD) sub-scores from baseline to W12 4. Self-rating Depression Scale (SDS) scores from baseline to W12 5. Leeds Sleep Evaluation Questionnaire (LSEQ) scores from W2 to W12 6. Safety from baseline to Wend (final visit) |
| Overall study start date | 27/04/2010 |
| Completion date | 31/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 390 |
| Key inclusion criteria | 1. Out-patients of both genders aged between 18 (or legal majority) and 65 years of age (inclusive) 2. Fulfilling American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria for GAD |
| Key exclusion criteria | 1. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD within 6 months prior to selection 2. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women 3. Any relevant clinical abnormality detected during physical examinations, ECG or laboratory tests likely to interfere with the study conduct or evaluations |
| Date of first enrolment | 27/04/2010 |
| Date of final enrolment | 31/08/2011 |
Locations
Countries of recruitment
- Argentina
- Czech Republic
- Finland
- Korea, South
- Poland
- Russian Federation
- Slovakia
Study participating centre
Mehilainen Clinic
Helsinki
00260
Finland
00260
Finland
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 | |||
| Results article | results | 01/04/2014 | Yes | 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.
