International clinical psychopharmacology
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Int Clin Psychopharmacol · Jan 2014
Randomized Controlled Trial Multicenter StudyPooled analysis of adjunct extended-release quetiapine fumarate in patients with major depressive disorder according to ongoing SSRI or SNRI treatment.
This pooled analysis evaluated the efficacy of extended-release quetiapine fumarate (quetiapine XR) adjunct to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) in patients with major depressive disorder (MDD). Pooled data were analyzed from two 6-week, double-blind, randomized, placebo-controlled trials of adjunct quetiapine XR (150 and 300 mg/day) in patients with MDD and inadequate response to initial antidepressant monotherapy. This post-hoc analysis included evaluation of change from randomization at week 6 in Montgomery Åsberg Depression Rating Scale (MADRS) total scores (primary endpoint), and week 6 MADRS response and remission rates for quetiapine XR as an adjunct to ongoing SSRI or SNRI. ⋯ At week 6, quetiapine XR 150 mg/day+SSRI and 300 mg/day+SSRI reduced the MADRS total score from randomization versus placebo+SSRI [least squares mean (LSM) change, -14.70 (P<0.05) -14.72 (P<0.05) vs. -12.59, respectively]. Quetiapine XR 150 mg/day+SNRI (LSM change, -14.68, P<0.01) and 300 mg/day+SNRI (LSM change, -14.99, P<0.01) also reduced the MADRS total score from randomization at week 6 versus placebo+SNRI (-10.77). In conclusion, in patients with MDD and inadequate response to ongoing antidepressant, adjunct quetiapine XR (150 and 300 mg/day) was effective in both SSRI and SNRI subgroups.
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Int Clin Psychopharmacol · Sep 2013
Randomized Controlled Trial Multicenter StudyThe effects of aripiprazole on the subscales of the Kellner Symptom Questionnaire in treatment resistant depression.
We have recently examined the efficacy of low-dose aripiprazole augmentation for major depressive disorder (MDD), with modest nonsignificant benefit found. In a secondary investigation, we examined whether aripiprazole resulted in improvement in four subscales (depression, anxiety, somatic symptoms, and hostility) of the Kellner Symptom Questionnaire (KSQ). We reanalyzed data from the main outcome study on 221 MDD patients with inadequate response to selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. ⋯ Aripiprazole augmentation resulted in a significant improvement compared with placebo augmentation only in the depression subscale of the KSQ; however, the low dose may not have been enough to have an impact on the anxiety and hostility scales. The good tolerability of the low dose may have resulted in the absence of worsening of somatic symptoms. Prospective studies are needed to better characterize the impact of low doses of aripiprazole augmentation on different manifestations of MDD.
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Int Clin Psychopharmacol · May 2012
Randomized Controlled Trial Comparative StudyCombination of citalopram plus paliperidone is better than citalopram alone in the treatment of somatoform disorder: results of a 6-week randomized study.
The objective of this study was to evaluate the effectiveness and tolerability of citalopram versus citalopram plus paliperidone combination therapy in patients with somatoform disorders (SDs). In this 6-week, randomized, fixed-dose study, 60 patients with SD (ICD-10 F45.0), undifferentiated SD (F45.1), and somatoform autonomic dysfunction (F45.3) were randomly assigned to receive citalopram (20 mg/day) with or without paliperidone (3 mg/day). ⋯ Our findings indicate that a combination with paliperidone is significantly better than monotherapy with citalopram whether synergistic or add-on for patients with SDs. Our results call for future studies with larger sample sizes and a longer duration to draw more definitive conclusions.
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Int Clin Psychopharmacol · May 2012
Randomized Controlled Trial Multicenter StudyAdjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment.
This study evaluated the efficacy of adjunctive pregabalin versus placebo for treatment of patients with generalized anxiety disorder (GAD) who had not optimally responded to previous or prospective monotherapies. This was a phase 3, randomized, double-blind, placebo-controlled study. Patients diagnosed with GAD who had a historical and current lack of response to pharmacotherapy [Hamilton Anxiety Rating Scale (HAM-A) of ≥ 22 at screening] were randomized to adjunctive treatment with either pregabalin (150-600 mg/day) or placebo. ⋯ Adverse events were consistent with previous studies and discontinuations were infrequent for pregabalin (4.4%) and placebo (2.3%). The study was discontinued early after an interim analysis. The results indicate that adjunctive pregabalin is an efficacious therapy for patients with GAD who experience an inadequate response to established treatments.
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Int Clin Psychopharmacol · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of risperidone oral solution and intramuscular haloperidol with the latter shifting to oral therapy for the treatment of acute agitation in patients with schizophrenia.
This randomized, parallel-group, open study investigated the efficacy and safety of risperidone oral solution (RIS-OS) in combination with clonazepam and intramuscular haloperidol for the treatment of acute agitation in patients with schizophrenia, and the study explored the possibility of decreasing the efficacy of an acute 6-week treatment by switching intramuscular haloperidol injection to RIS-OS. Two hundred and five agitation-exhibiting schizophrenic inpatients at six hospitals were originally included in the study. The 47-day trial consisted of 5 days (session I) of receiving either oral treatment (RIS-OS plus clonazepam) or intramuscular treatment (intramuscular haloperidol) and a 42-day (session II) period of either withdrawing from clonazepam or shifting from intramuscular haloperidol to a RIS-OS period. ⋯ Efficacy was not significantly different between the two treatment groups after the 6-week treatment (P>0.05). However, combination treatment exhibited greater efficacy, and adverse events, especially extrapyramidal symptoms, were lower with the oral treatment than with the intramuscular treatment in session I. These results show that RIS-OS in combination with clonazepam is an effective treatment, comparable with intramuscular haloperidol, and is well-tolerated for acute agitation in patients with schizophrenia.