Agomelatine adjunctive therapy for acute bipolar depression: preliminary open data.
OBJECTIVE
Agomelatine has been shown to be safe and efficient in the treatment of major depressive disorder at 25 mg daily. The aim of this study was to gather preliminary data regarding the antidepressant efficacy of agomelatine in patients with bipolar I disorder experiencing a major depressive episode.


METHODS
Bipolar I patients on lithium (n = 14) or valpromide (n = 7), with a Hamilton Rating Scale for Depression (HAM-D-17) total score > or = 18, were given adjunctive open-label agomelatine at 25 mg/day for a minimum of 6 weeks followed by an optional extension of up to an additional 46 weeks.


RESULTS
Using intent-to-treat data, 81% of patients met criteria for marked improvement (>50% improvement from baseline in HAM-D score) at study endpoint. Patients were severely depressed at study entry (HAM-D of 25.2) and 47.6% responded as early as at one week of treatment. Nineteen patients entered the optional extension period for a mean of 211 days (range 6-325 days). Eleven patients completed the one-year extension on agomelatine. There were no dropouts due to adverse events during the acute phase of treatment (6 weeks). Six patients experienced serious adverse events during the one-year period. Three lithium-treated patients experienced manic or hypomanic episodes during the optional extension period, one of which was treatment-related.


CONCLUSIONS
These results indicate the effectiveness of agomelatine 25 mg in the treatment of depressed bipolar I patients co-medicated with lithium or valpromide. A randomized controlled trial is planned to confirm these results.
Calabrese
Joseph R
JR
University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH 44106, USA. joseph.calabrese@uhhospitals.org
Guelfi
Julien Daniel
JD
Perdrizet-Chevallier
Catherine
C
D000081:Acetamides / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000503:physiopathology; D003866:Depressive Disorder / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D009281:Naphthalenes
D000081:Acetamides; D018692:Antimanic Agents; D018020:Lithium Compounds; D014635:Valproic Acid; C084711:agomelatine; D009281:Naphthalenes; C004651:dipropylacetamide