Naltrexone augmentation in OCD: A double-blind placebo-controlled cross-over study
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Clomipramine
Fluvoxamine
In a double‐blind study we compared fluvoxamine, a new selective serotonin re‐uptake inhibitor, with clomipramine. In 36 female in‐patients with vital depression, the antidepressant properties of fluvoxamine and clomipramine were studied. Eight patients did not complete the study. During a 4‐week treatment period the Hamilton‐, Zung‐, Clinical Global Impression‐ and Leyden ratings showed, apart from the last scale in the fluvoxamine group, significant improvement in both groups. In the latter scale, a statistically significant difference was found in favour of clomipramine. Additional anxiolytic‐sedative medication was required equally in both groups. CSF data in 10 patients are discussed. Non‐specific electrocardio‐graphic (ECG) repolarization disturbances were observed in both groups. Anticholinergic side effects were more prominent with clomipramine than with fluvoxamine; gastrointestinal symptoms and agitation were more prominent with fluvoxamine than with clomipramine. Fluvoxamine did not show particular advantages or disadvantages over clomipramine.
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Fluvoxamine
Clinical Global Impression
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The aim of this prospectively randomized, double-blind, parallel group, multicentre study was to compare the efficacy and tolerability of fluvoxamine and clomipramine in patients suffering from obsessive-compulsive disorder (OCD) (DSM-III-R). Fourteen centres participated in this trial. Sixty-eight patients were randomized to receive fluvoxamine and 65 to receive clomipramine. The duration of the study was 10 weeks. The two treatment groups showed a marked improvement of obsessive-compulsive symptomatology, as determined by the Yale-Brown Obsessive-Compulsive Scale, the National Institute of Mental Health Obsessive-Compulsive Global Scale and Clinical Global Impression. No statistically significant differences were found between fluvoxamine and clomipramine in terms of efficacy during the study. A similar number of patients in each group withdrew from the study prematurely, but there were more dropouts due to adverse events in the clomipramine group. Concerning tolerability, there were significantly more reports of constipation and dry mouth in the clomipramine group. The results show that fluvoxamine and clomipramine have similar efficacy in the treatment of patients suffering from OCD, but fluvoxamine is better tolerated. In view of the superior safety profile of fluvoxamine compared to clomipramine in terms of a risk-benefit assessment, the use of fluvoxamine would appear to be advantageous for this patient population.
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Fluvoxamine
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Clinical Global Impression
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Fluvoxamine 25-200 mg daily and clomipramine 25-200 mg daily were given for separate three week periods to 18 subjects with narcolepsy and cataplexy. Both drugs improved cataplexy but not narcolepsy. Fluvoxamine was less active than clomipramine, but both drugs abolished cataplexy in individual subjects. Gastrointestinal side effects prevented treatment with fluvoxamine in five subjects. All patients completed the clomipramine phase of the trial, but two men complained of delayed ejaculation. Fluvoxamine is a more potent inhibitor of 5-hydroxytryptamine (5-HT) reuptake in some systems, but not in others. It is therefore uncertain whether the greater anticataplectic effect of clomipramine is due to a greater inhibition of 5-HT reuptake or to other mechanisms.
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To inform dosing and describe the pharmacokinetic interaction, efficacy and safety of fluvoxamine-clomipramine combination therapy for treatment-resistant pediatric obsessive-compulsive disorder (OCD).A retrospective chart review of OCD-affected patients at a tertiary care children's hospital between January 2010 and August 2017 was conducted. Those included were 18 years of age or younger at initiation of fluvoxamine-clomipramine combination therapy and had at least one set of serum concentration values capturing clomipramine and desmethylclomipramine levels.Six adolescents met study inclusion criteria. Fluvoxamine adequately inhibited clomipramine metabolism to desmethylclomipramine in a dose-dependent manner. Fluvoxamine-clomipramine combination therapy was generally well tolerated with no serious or life-threatening adverse effects reported.Fluvoxamine-clomipramine combination therapy permits use of lower clomipramine doses than typically used as clomipramine monotherapy and appears to be a safe alternative for pediatric OCD patients failing sequential selective serotonin reuptake inhibitor monotherapy trials. Inter-patient variability and saturable kinetics support therapeutic drug monitoring of serum clomipramine and desmethylclomipramine concentrations to optimize therapy. A proposed algorithm that aligns with current OCD treatment guidelines is described. Further study is needed to evaluate efficacy of this approach.Préciser la posologie et décrire l’interaction pharmacocinétique, l’efficacité et l’innocuité de la thérapie combinée fluvoxamine-clomipramine pour le trouble obsessionnel-compulsif (TOC) pédiatrique réfractaire au traitement.Une revue de dossiers rétrospective de patients souffrant du TOC à un hôpital pour enfants de soins tertiaires entre janvier 2010 et août 2017 a été menée. Les patients inclus avaient 18 ans ou moins lors de l’initiation de la thérapie combinée fluvoxamine-clomipramine et avaient au moins une série de valeurs de concentration sérique pour le captage des taux de clomipramine et de desméthylclomipramine.Six adolescents satisfaisaient aux critères d’inclusion de l’étude. La fluvoxamine inhibait adéquatement le métabolisme de la clomipramine pour la desméthylclomipramine de manière dose-dépendante. La thérapie combinée fluvoxamine-clomipramine était généralement bien tolérée sans effets indésirables sérieux ou dangereux déclarés.La thérapie combinée fluvoxamine-clomipramine permet d’utiliser des doses plus faibles de clomipramine que celles habituellement utilisées en monothérapie de clomipramine et semble être une solution de rechange sûre pour les patients du TOC pédiatrique qui ne répondent pas aux essais de monothérapie d’inhibiteurs sélectifs séquentiels de recaptage de la sérotonine. La variabilité inter-patients et la cinétique saturable soutiennent le contrôle des médicaments thérapeutiques et des concentrations sériques de clomipramine et de desméthylclomipramine afin d’optimiser la thérapie. Un algorithme proposé qui correspond aux lignes directrices du traitement du TOC est décrit. Il faut d’autres études pour évaluer l’efficacité de cette approche.
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Fluvoxamine
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Fluvoxamine
Clomipramine
Demethylation
Hydroxylation
Tricyclic
Serotonin reuptake inhibitor
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Objective To study the efficacy and adverse reactions of fluvoxamine and clomipramine in the treatment of adolescents with OCD.Methods 42 adolescents with OCD were randomized into fluvoxamine group(21 cases) and clomipramine group(21 cases) treated with fluvoxamine and clomipramine respectively for 8 weeks.All patients were assessed with Yale-Brown Obsessive Compulsive Scale(Y-BOCS) and Hamilton Anxiety Scale(HAMA) to evaluate the efficiency and were assessed with Treatment Emergent Symptom Scale(TESS) to evaluate the side effects.Results There was no significant difference in response rate between fluvoxamine group and clomipramine group(86.4% vs.86.4%,P = 1.00).Compared with the baseline,scores of Y-BOCS and HAMA in both groups decreased significantly at the 4th,8th week of the treatment(P 0.01).The rate of adverse reactions in fluvoxamine group was significantly lower than that in clomipramine group(35% vs.70%,P 0.05).Conclusion Fluvoxamine is safe and effective in the treatment of adolescents with OCD.
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(1) Four drugs are approved in France for patients with obsessive-compulsive disorders, namely clomipramine and three selective serotonin reuptake inhibitors (SSRIs): fluoxetine, paroxetine and sertraline. None of the four has emerged as a reference treatment. For children with obsessive-compulsive disorder, the treatment hierarchy is as follows: psychotherapy; behaviour therapy; clomipramine; sertraline. (2) Fluvoxamine, another SSRI, has now been approved in France for the treatment of obsessive-compulsive disorder in patients aged at least 8 years, after European harmonisation of SPCs for fluvoxamine-based preparations. (3) In adults, two placebo-controlled trials and the six trials versus clomipramine show that fluvoxamine, like clomipramine, is only partially effective (about one-third of patients "respond"). (4) In the only placebo-controlled trial in 120 children and adolescents aged from 8 to 17 years, who were treated for 10 weeks, efficacy was even more modest (response rate 15%, compared to 10% with placebo). (5) The safety profile of fluvoxamine is the same as that of all SSRIs but it has a potential for more drug interactions. (6) In practice, approval of fluvoxamine in adults or children with obsessive-compulsive disorder will have no impact on their management.
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We describe the case of a depressive patient who was a rapid metabolizer of CYP2D6 substrates and a heavy smoker, and who did not respond to several courses of treament with antidepressants, as a result of unusually low drug-plasma levels. During hospitalization, he did not improve after treatment with clomipramine (150 - 225 mg/day during three weeks), but showed a response within four days after addition of fluvoxamine (100 mg/day). Plasma levels of clomipramine and desmethylclomipramine changed from 58 ng/ml and 87 ng/ml to 223 ng/ml and 49 ng/ml respectively one week after addition of fluvoxamine. Present knowledge of the role of cytochrome P-450 isozymes, such as CYP1A2, CYP2C19, CYP2D6, and CYP3A4, in the metabolism of psychotropic drugs as well as therapeutic drug-plasma level monitoring may thus help to determine individual treatment.
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Clomipramine
Therapeutic Drug Monitoring
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A double-blind trial was carried out to assess the efficacy and safety of fluvoxamine, a selective serotonin reuptake inhibitor, in comparison with clomipramine, a classical tricyclic antidepressant, in the treatment of obsessive-compulsive disorder. A total of 26 individuals with obsessive-compulsive disorder and with no comorbid disorders at baseline were included in the study. The obsessive-compulsive disorder symptom severity was rated using the Yale-Brown Obsessive-Compulsive Scale and the Clinical Global Impression Scale. The primary efficacy measures indicated an equal improvement in the two groups (38% in the patients taking fluvoxamine and 40% in those taking clomipramine, as compared with baseline values), but onset was faster in the clomipramine group. Side effects, in particular anticholinergic side effects, were more prominent in the clomipramine group. The present double-blind trial confirms an equal efficacy of clomipramine and fluvoxamine in obsessive-compulsive patients. Although clomipramine had a faster onset, fluvoxamine was better tolerated, so that it seems more suitable for long-term treatment of obsessive-compulsive patients.
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Fluvoxamine
Clinical Global Impression
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OBJECTIVE: To compare the efficacy and safety of fluvoxamine and clomipramine in the treatment of obsessive-compulsive disorder.METHODS: Retrieved from CNKI,Wanfang database,VIP database,domestic published RCT about fluvoxamine vs.clomipramine in the treatment of obsessive-compulsive disorder were collected,and the methodology of included studies was evaluated.Rev Man 4.2 statistical software was used for Meta-analysis.RESULTS: A total of 11 RCT were included,involving 625 patients.Meta-analysis showed that the total effective rate [OR=1.12,95%CI(0.88,1.55),P=0.51] and cure rate [OR=1.20,95%CI(0.80,1.80),P=0.38] of fluvoxamine were not statistically significant different from those of clomipramine;the incidence of ADR in fluvoxamine group was significantly lower than in clomipramine group,there was statistical significance(P0.05).CONCLUSIONS: Efficacy of fluvoxamine is similar to clomipramine in the treatment of obsessive-compulsive disorder,but shows better safety.
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