Multicenter double-blind randomized parallel-group clinical trial of efficacy of the combination clomipramine (150 mg/day) plus lithium carbonate (750 mg/day) versus clomipramine (150 mg/day) plus placebo in the treatment of unipolar major depression

Background: The therapeutic efficacy of adding lithium to an ongoing antidepressant in resistant depression is well known. However there is less data concerning the efficacy of giving lithium and antidepressant concurrently from the start of treatment. Methodology: The primary objective of this stud...

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Bibliographic Details
Published in:Journal of affective disorders 2003-09, Vol.76 (1), p.191-200
Main Authors: Januel, Dominique, Poirier, Marie-France, D’alche-Biree, Françoise, Dib, Michel, Olié, Jean-Pierre
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Antidepressive Agents - administration & dosage
Antidepressive Agents - pharmacology
Antidepressive Agents - therapeutic use
Antidepressive Agents, Tricyclic - administration & dosage
Antidepressive Agents, Tricyclic - pharmacology
Antidepressive Agents, Tricyclic - therapeutic use
Biological and medical sciences
Clomipramine - administration & dosage
Clomipramine - pharmacology
Clomipramine - therapeutic use
Depressive Disorder - drug therapy
Double-Blind Method
Drug Therapy, Combination
Efficacy
Female
Humans
Lithium Carbonate - administration & dosage
Lithium Carbonate - pharmacology
Lithium Carbonate - therapeutic use
Lithium+clomipramine combination
Male
Medical sciences
Middle Aged
Neuropharmacology
Pharmacology. Drug treatments
Placebos
Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease)
Psychology. Psychoanalysis. Psychiatry
Psychopharmacology
Severity of Illness Index
Treatment of depression
Treatment Outcome
Unipolar depression
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Summary:Background: The therapeutic efficacy of adding lithium to an ongoing antidepressant in resistant depression is well known. However there is less data concerning the efficacy of giving lithium and antidepressant concurrently from the start of treatment. Methodology: The primary objective of this study was to compare the efficacy of a combination of clomipramine+lithium (C+L) with that of clomipramine+placebo (C+P) in-patients with unipolar major depression, during the first 11 days of treatment. Secondary objectives were the assessment of effectiveness after 6 weeks and assessment of the safety of the combination clomipramine and lithium carbonate. C+L and C+P groups were compared for 6 weeks in a multicenter randomized trial of 141 patients hospitalized with a DSM-IV diagnosis of major depression. Efficacy was evaluated using the standard MADRS and CGI scales. Results: Analysis of the ‘as treatment ITT’ population showed: the percentage reduction in MADRS scores between D0 and D11 in this population was better in the C+L group but not statistically significant (C+L: 32.1 vs. C+P: 27.4, P=0.07). Nevertheless, the comparison of mean MADRS scores showed a significant difference in the C+L group on days 4 (C+L: 25.1 vs. C+P: 27.8) and 7 (C+L: 18.6 vs. C+P: 21.5), P
ISSN:0165-0327
1573-2517
DOI:10.1016/S0165-0327(02)00086-1