A study to determine the maintenance of efficacy of agomelatine (25 mg to 50 mg) to prevent relapse in out-patients with Major Depressive Disorder. A 8 to 10 weeks open period treatment with agomelatine (25 mg to 50 mg) followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 3.3 Level: P.T. Classification code 10025453

• Registration Number: EUCTR2004-003981-13-GB
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2007-07-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Selection criteria
- Out-patients
- Fulfilling DSM IV-TR criteria for Major Depressive Disorder of moderate or severe intensity:
- Recurrent episode and at the beginning of the index episode patients must have been free of depressive symptoms of their previous episode for at least 6 months,
- With or without melancholic features according DSM IV-TR criteria
- Without seasonal pattern according DSM IV-TR criteria
- Without psychotic features,
- Without post partum onset for the current episode,
- Current episode >or= 8 weeks

Inclusion Criteria For The Open Period:
- HAM-D 17-item score still >or= 22 and decrease (if any) between ASSE and W0 = 20%.
- Sum of items H1+H2+H5+H6+H7+H8+H10+H13 of HAM-D 17-item >or= 55% HAM-D 17-item total score.
- CGI item 1: Severity of illness >or= 4 (moderately ill to severely ill).
- Hospital Anxiety Depression Scale: HAD completed and HAD-D sub-score >or=11,

Randomisation criteria For The Double Blind Period:
- Patients having completed the 8 to 10 weeks of open” treatment.
- Patients improved by agomelatine 25 mg or 50 mg after 8 to 10 weeks of open” treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Non selection Criteria
- All types of depression other than Major Depressive Disorder
- Severe or uncontrolled organic disease, likely to interfere with the conduct of the study (e.g. neoplastic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled clinically significant arterial hypertension). Patients whose state is stabilized under treatment may be included.

Non Inclusion Criteria For The Open Period:
- Any non-selection criteria which could have appeared after the selection visit.
- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory test likely to interfere with the study conduct or evaluation.
- Positive pregnancy test.
- gGT or transaminases values > 3 times the upper limit or blood creatinin > 150 mmol/l.
- IVRS refusal.

Non randomisation Criteria:
- IVRS refusal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified