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Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder

Published online by Cambridge University Press:  26 February 2014

Claudio N. Soares ,
Jean Endicott ,
Matthieu Boucher ,
Rana S. Fayyad  and
Christine J. Guico-Pabia
Claudio N. Soares*
Affiliation:
Department of Psychiatry and Behavioural Neurosciences, McMaster University & St. Joseph's Healthcare, Hamilton, Ontario, Canada
Jean Endicott
Affiliation:
Department of Psychiatry, Columbia University, New York, New York, USA
Matthieu Boucher
Affiliation:
Medical Affairs, Pfizer CanadaInc, Kirkland, Quebec, Canada
Rana S. Fayyad
Affiliation:
Department of Statistics, PfizerInc, New York, New York, USA
Christine J. Guico-Pabia
Affiliation:
Medical Affairs, Pfizer Inc, Collegeville, Pennsylvania, USA
*
Address for correspondence: Claudio N. Soares, MD, PhD, FRCPC, Women's Health Concerns Clinic, 301 James St. South FB638, Hamilton, ON, Canada. (Email [email protected])
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Abstract

Background

The predictive value of early functional improvement for treatment success at week 8 was assessed in a pooled analysis in patients with major depressive disorder (MDD).

Methods

Data were pooled from 7 double-blind studies in adult patients with MDD randomly assigned to desvenlafaxine 50 mg/d or placebo. Four levels of treatment success were determined at week 8 for patients with baseline Sheehan Disability Scale (SDS) score > 12 (N = 2156): functional response (SDS ≤12 and ≥50% improvement in SDS), functional/depression response (SDS ≤12 and ≥50% improvement in both SDS and 17-item Hamilton Rating Scale for Depression [HAM-D17] score), functional remission (SDS < 7), and functional/depression remission (SDS < 7 and HAM-D17 ≤7). Week 2 improvement in SDS was evaluated as a predictor of later functional response/remission using receiver operating characteristic analysis. Odds ratios (ORs) of the predictability of improvement thresholds were computed from a logistic regression model.

Results

The proportion of patients achieving each level of treatment success was significantly greater for patients treated with desvenlafaxine (40%, 32%, 23%, 15%, respectively) vs placebo (31%, 22%, 17%, 10%; all P ≤ 0.002). Early change in SDS was a highly significant predictor of functional response/remission (ORs, 0.958–0.970; all P < 0.0001).

Discussion

Patients’ early functional response to desvenlafaxine 50 mg/d is predictive of treatment success.

Keywords

Antidepressantsmajor depressive disorderpredictive value of teststreatment outcome
Type
Original Research
Information
CNS Spectrums , Volume 19 , Issue 6 , December 2014 , pp. 519 - 527
Copyright
Copyright © Cambridge University Press 2014 

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Footnotes

This study was sponsored by Pfizer. Medical writing support was provided by Kathleen Dorries, PhD, of Peloton Advantage and was funded by Pfizer.

Clinical Trial Registry Numbers: 332: www.clinicaltrials.gov, NCT00277823; 333: www.clinicaltrials.gov, NCT00300378; 335: www.clinicaltrials.gov, NCT00384033; 3359: www.clinicaltrials.gov, NCT00798707; 3362: www.clinicaltrials.gov, NCT00863798; 3364: www.clinicaltrials.gov, NCT01121484; 4415: www.clinicaltrials.gov, NCT00824291.

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