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Prognostic subgroups for citalopram response in the STAR*D trial.

ABSTRACT: Few data exist to help clinicians predict likelihood of treatment response in individual patients with major depressive disorder (MDD). Our aim was to identify subgroups of MDD patients with differential treatment outcomes based on presenting clinical characteristics. We also sought to quantify the likelihood of treatment success based on the degree of improvement and side effects after 2 and 4 weeks of selective serotonin reuptake inhibitor (SSRI) pharmacotherapy.We analyzed data from the first treatment phase of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, in which subjects with a DSM-IV diagnosis of MDD were treated for 8-14 weeks with open-label citalopram. A receiver operating characteristic (ROC) analysis was conducted to determine homogenous subgroups with different rates of response and remission in depressive symptoms. Included predictor variables were initial clinical characteristics, initial improvement, and side effects after 2 and 4 weeks of SSRI treatment. The primary outcome measures were treatment response (defined as a greater than 50% reduction in 17-item Hamilton Depression Rating Scale [HDRS-17] score from baseline) and remission (defined as an HDRS-17 score ? 17).Baseline clinical characteristics were able to identify subgroups from a low likelihood of response of 18% (income < $10,000, comorbid generalized anxiety disorder, < 16 years of education; P < .01) to a high likelihood of response of 68% (income ? $40,000, no comorbid posttraumatic stress disorder; P < .01). Among baseline clinical characteristics, employment status (N = 2,477; ?²? = 78.1; P < .001) and income level (N = 2,512; ?²? = 77.7; P < .001) were the most informative in predicting treatment outcome. For the models at weeks 2 and 4, treatment success was best predicted by early symptom improvement.Socioeconomic data such as low income, education, and unemployment were most discriminative in predicting a poor response to citalopram, even with disparities in access to care accounted for. This finding implies that socioeconomic factors may be more useful predictors of medication response than traditional psychiatric diagnoses or past treatment history.ClinicalTrials.gov identifier: NCT00021528.

SUBMITTER: Jakubovski E

PROVIDER: S-EPMC4471174 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Prognostic subgroups for citalopram response in the STAR*D trial.

Jakubovski Ewgeni E Bloch Michael H MH

The Journal of clinical psychiatry 20140701 7

<h4>Objective</h4>Few data exist to help clinicians predict likelihood of treatment response in individual patients with major depressive disorder (MDD). Our aim was to identify subgroups of MDD patients with differential treatment outcomes based on presenting clinical characteristics. We also sought to quantify the likelihood of treatment success based on the degree of improvement and side effects after 2 and 4 weeks of selective serotonin reuptake inhibitor (SSRI) pharmacotherapy.<h4>Method</h ...[more]

PMID: 24912106

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Project description:Most patients with anxiety disorders receive treatment in primary care settings. Limited moderator data are available to inform clinicians of likely prognostic outcomes for individual patients. We identify baseline characteristics associated with outcome in adults seeking treatment for anxiety disorders.We conducted an exploratory moderator analysis from the Coordinated Anxiety Learning and Management (CALM) trial. In the CALM trial, 1,004 adults who met DSM-IV criteria for generalized anxiety disorder (GAD), panic disorder, social anxiety disorder, and/or posttraumatic stress disorder (PTSD) were randomized to usual care (UC) or a collaborative care intervention (ITV) of cognitive-behavioral therapy and/or pharmacotherapy between June 2006 and April 2008. Logistic regression was used to examine baseline characteristics associated with remission and response overall and by treatment condition. Receiver operating curve (ROC) analyses identified subgroups associated with similar likelihood of response and remission of global anxiety symptoms. Remission was defined as score < 6 on the 12-item Brief Symptom Inventory (BSI-12) anxiety and somatization subscales. Response was defined as at least 50% reduction on BSI-12, or meeting remission criteria.Randomization to ITV over UC was often the strongest predictor of outcome. Several baseline patient characteristics were associated with poor treatment outcome including comorbid depression, increased severity of underlying anxiety disorder(s) (P < .001), low socioeconomic status (perceived [P < .001] and actual [P < .05]), and limited social support (P < .001). Patient characteristics associated with particular benefit from ITV were being female (P < .05), increased depression (P < .01)/GAD severity (P < .05), and low socioeconomic status (P < .05). ROC analysis demonstrated prognostic subgroups with large differences in response likelihood.Further research should focus on the effectiveness of implementing the ITV intervention of CALM in community treatment centers where patients typically are of low socioeconomic status and may particularly benefit from ITV.ClinicalTrials.gov identifier: NCT00347269.

Dataset Information

Prognostic subgroups for citalopram response in the STAR*D trial.

Publications

Prognostic subgroups for citalopram response in the STAR*D trial.

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