A pooled analysis of two randomised, placebo-controlled studies of extended release quetiapine fumarate adjunctive to antidepressant therapy in patients with major depressive disorder

Bauer, Michael; El-Khalili, Nizar; Datto, Catherine; Szamosi, Johan; Eriksson, Hans

doi:10.1016/j.jad.2010.08.032

Cited by 78 publications

(56 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Category C recommendations include psychostimulants and anticonvulsants. It must be noted that the BAP guidelines were formulated before the current body of evidence for aripiprazole and quetiapine was available [22][23][24]. The ICSI healthcare guidelines were developed for the treatment of major depression in primary care in the USA [11].…”

Section: Augmentation Strategies In Other Guidelinesmentioning

confidence: 99%

Atypical Antipsychotic Augmentation Strategies in the Context of Guideline-based Care for the Treatment of Major Depressive Disorder

Patkar

Pae

2013

CNS Drugs

View full text Add to dashboard Cite

There is a growing body of evidence that supports the use of atypical antipsychotics as augmentation agents for nonpsychotic unipolar major depressive disorder (MDD) in adults. Unfortunately, varying definitions of treatment-resistant depression, the limited evidence available for interventions after two or more treatment failures, and when and whether to use medications from nonantidepressant classes, remain a key gap in the knowledge base for clinicians. We identified and reviewed the following guidelines to discuss the status of augmentation therapy with atypical antipsychotic agents in MDD: American Psychiatric Association practice guidelines for treatment of patients with MDD; Canadian

show abstract

Section: Augmentation Strategies In Other Guidelinesmentioning

confidence: 99%

Atypical Antipsychotic Augmentation Strategies in the Context of Guideline-based Care for the Treatment of Major Depressive Disorder

Patkar

Pae

2013

CNS Drugs

View full text Add to dashboard Cite

show abstract

“…Quetiapine XR, in addition to efficacy as monotherapy in adults with schizophrenia, bipolar mania, and bipolar depression, has efficacy as monotherapy in adults with generalized anxiety disorder and as both monotherapy and adjunctive therapy in adults with major depressive disorder (MDD) (Kahn et al 2007;Weisler et al 2009;Bandelow et al 2010;Bauer et al 2010;Suppes et al 2010;Cutler et al 2011).…”

mentioning

confidence: 99%

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Findling

Pathak

Earley³

et al. 2014

Journal of Child and Adolescent Psychopharmacology

View full text Add to dashboard Cite

Objective: Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania. Large, placebo-controlled studies of interventions in pediatric bipolar depression are lacking. The current study investigated the efficacy and safety of quetiapine extended-release (XR) in patients 10-17 years of age, with acute bipolar depression. Methods: This multicenter, double-blind, randomized, placebo-controlled study investigated quetiapine XR (dose range, 150-300 mg/day) in pediatric outpatients with an American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I or bipolar II disorder (current or most recent episode depressed) treated for up to 8 weeks (ClinicalTrials.gov identifier: NCT00811473). The primary study outcome was mean change in Children's Depression Rating Scale-Revised (CDRS-R) total score. Secondary efficacy outcomes included CDRS-R-based response and remission rates. Results: Of 193 patients randomized to treatment, 144 patients completed the study (75.3% of quetiapine XR group [n = 70]; 74.0% of placebo group [n = 74]). Least squares mean changes in CDRS-R total score at week 8 were: -29.6 (SE, 1.65) with quetiapine XR and -27.3 (SE, 1.60) with placebo, a between-treatment group difference of -2.29 (SE, 1.99; 95% CI, -6.22, 1.65; p = 0.25; mixed-model for repeated measures analysis). Rates of response and remission did not differ significantly between treatment groups. The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release (IR). Potentially clinically significant elevations in clinical chemistry values included triglycerides (9.3%, quetiapine XR; 1.4%, placebo group) and thyroid stimulating hormone (4.7%, quetiapine XR; 0%, placebo group). An adverse event potentially related to diabetes mellitus occurred in 3.3% of the quetiapine XR versus no adverse events in the placebo group. Conclusions: Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression. Quetiapine XR was generally safe and well tolerated.

show abstract

“…0.2 kg in the quetiapine-XR 300 mg/day, 150 mg/ day and placebo groups, respectively. Moreover, the proportions of patients in each group showing weight gains of 7 % or more were 7.2 %, 3.2 % and 1.7 %, respectively, revealing a dose-dependent increase [23]. Extrapyramidal symptom measures and adverse events were generally low and equal between the quetiapine and placebo groups.…”

Section: Quetiapinementioning

confidence: 89%

“…Furthermore, McIntyre and Gendron [22] found no significant difference in the rates of response or remission between quetiapine and placebo. However, the pooled analysis of the two largest studies (n = 936) found a significant benefit of quetiapine augmentation in MADRS total score, response rate and remission rate at week 6 and at the study endpoint compared with placebo augmentation [23]. As for adverse events in this pooled analysis, the most common and clinically significant side effects were somnolence (quetiapine: 300 mg; 26.0 %, 150 mg; 22.5 %; placebo: 3.6 %) and sedation (quetiapine: 300 mg, 17.0 %; quetiapine: 150 mg, 13.0 %; placebo: 4.2 %) [23].…”

Section: Quetiapinementioning

confidence: 95%

See 1 more Smart Citation

Augmentation Treatments with Second-generation Antipsychotics to Antidepressants in Treatment-resistant Depression

Kato

Chang

2013

CNS Drugs

View full text Add to dashboard Cite

Various classes of antidepressants have been used in the treatment of major depressive disorder (MDD); however, the efficacy of these treatments remains uncertain. A number of well-controlled clinical trials, meta-analyses and practical clinical studies have found that approximately 30 % of MDD patients remit following antidepressant treatment, leaving approximately 70 % of patients with significant residual symptoms. In these latter patients with what is considered treatment-resistant MDD, typical antipsychotics have sometimes been administered in order to augment the antidepressant effects but safety and tolerability concerns significantly reduce their usage in MDD patients. The advent of second-generation antipsychotics (SGAs), which have diverse pharmacodynamic profiles relative to antidepressants, has dramatically increased the usage of such drugs for patients with MDD. Recently, SGAs such as aripiprazole, quetiapine and olanzapine in combination with fluoxetine have been approved for the treatment of MDD, especially in the case of treatment resistance. This article reviews the efficacy and tolerability of SGA augmentation when added to antidepressant therapy for treatment-resistant MDD patients in acute phase studies published to date.

show abstract

A pooled analysis of two randomised, placebo-controlled studies of extended release quetiapine fumarate adjunctive to antidepressant therapy in patients with major depressive disorder

Cited by 78 publications

References 36 publications

Atypical Antipsychotic Augmentation Strategies in the Context of Guideline-based Care for the Treatment of Major Depressive Disorder

Atypical Antipsychotic Augmentation Strategies in the Context of Guideline-based Care for the Treatment of Major Depressive Disorder

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Augmentation Treatments with Second-generation Antipsychotics to Antidepressants in Treatment-resistant Depression

Contact Info

Product

Resources

About