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Depression: HELP
Articles by John M. Zajecka
Based on 13 articles published since 2010
(Why 13 articles?)
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Between 2010 and 2020, John Zajecka wrote the following 13 articles about Depression.
 
+ Citations + Abstracts
1 Review Residual symptoms and relapse: mood, cognitive symptoms, and sleep disturbances. 2013

Zajecka, John M. ·1700 W Van Buren St, 5th Floor, Chicago, IL 60612 john_zajecka@rush.edu. ·J Clin Psychiatry · Pubmed #24191972.

ABSTRACT: Remission is the standard of care in major depressive disorder (MDD). However, even in patients who respond to treatment and achieve remission, residual symptoms significantly inhibit functionality and increase the risk of relapse and recurrence. The most common residual symptoms are fatigue, sleep problems, and cognitive dysfunction. Clinicians should be cognizant of these potential residual symptoms and the unique ways in which they present in patients with MDD. Treating these symptoms as target symptoms from baseline increases the patient's chances of an asymptomatic remission. Making use of clinically practical screening instruments and monitoring these target symptoms throughout the course of treatment can improve patients' functional recovery.

2 Review Residual symptoms in major depressive disorder: prevalence, effects, and management. 2013

Zajecka, John / Kornstein, Susan G / Blier, Pierre. ·Depression Treatment Research Center, Rush University Medical Center, Chicago, Illinois, USA. ·J Clin Psychiatry · Pubmed #23656849.

ABSTRACT: -- No abstract --

3 Clinical Trial Adjunctive Lanicemine (AZD6765) in Patients with Major Depressive Disorder and History of Inadequate Response to Antidepressants: A Randomized, Placebo-Controlled Study. 2017

Sanacora, Gerard / Johnson, Michael R / Khan, Arif / Atkinson, Sarah D / Riesenberg, Robert R / Schronen, Juan P / Burke, Michael A / Zajecka, John M / Barra, Luis / Su, Hong-Lin / Posener, Joel A / Bui, Khanh H / Quirk, Michael C / Piser, Timothy M / Mathew, Sanjay J / Pathak, Sanjeev. ·Yale University School of Medicine, New Haven, CT, USA. · Sarkis Clinical Trials, Gainesville, FL, USA. · Northwest Clinical Research Center, Bellevue, WA, USA and Department of Psychiatry, Duke University School of Medicine, Durham, NC, USA. · Finger Lakes Clinical Research, Rochester, NY, USA. · Atlanta Center for Medical Research, Atlanta, GA, USA. · Welgemoed Medical Centre, Cape Town, South Africa. · iResearch Atlanta, Decatur, GA, USA. · Rush University Medical Center, Chicago, IL, USA. · Universidad de Antofagasta, Antofagasta, Chile. · AstraZeneca Pharmaceuticals LP, Wilmington, DE, and Cambridge, MA, USA. · Baylor College of Medicine, Houston and Michael E. Debakey VA Medical Center, Houston, TX, USA. ·Neuropsychopharmacology · Pubmed #27681442.

ABSTRACT: The objective of this study was to investigate the efficacy and safety of adjunctive lanicemine (NMDA channel blocker) in the treatment of major depressive disorder (MDD) over 12 weeks. This phase IIb, randomized, parallel-arm, double-blind, placebo-controlled study was conducted at 49 centers in four countries between December 2011 and August 2013 in 302 patients aged 18-70 years, meeting criteria for single episode or recurrent MDD and with a history of inadequate treatment response. Patients were required to be taking an allowed antidepressant for at least four weeks prior to screening. Patients were randomized equally to receive 15 double-blind intravenous infusions of adjunctive lanicemine 50 mg, lanicemine 100 mg, or saline over a 12-week course, in addition to ongoing antidepressant. The primary efficacy end point was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6. Secondary efficacy outcome variables included change in MADRS score from baseline to week 12, response and remission rates, and changes in Clinical Global Impression scale, Quick Inventory of Depressive Symptomology Self-Report score, and Sheehan Disability Scale score. Of 302 randomized patients, 240 (79.5%) completed treatment. Although lanicemine was generally well tolerated, neither dose was superior to placebo in reducing depressive symptoms on the primary end point or any secondary measures. There was no significant difference between lanicemine and placebo treatment on any outcome measures related to MDD. Post hoc analyses were performed to explore the possible effects of trial design and patient characteristics in accounting for the contrasting results with a previously reported trial.

4 Article A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. 2017

Aaronson, Scott T / Sears, Peter / Ruvuna, Francis / Bunker, Mark / Conway, Charles R / Dougherty, Darin D / Reimherr, Frederick W / Schwartz, Thomas L / Zajecka, John M. ·From the Sheppard Pratt Health System, Baltimore; Cyberonics, Inc., Houston; the Department of Psychiatry, Washington University in St. Louis; the Psychiatric Neuroscience Program, Massachusetts General Hospital, Boston; Psychiatric Behavior Solutions, Salt Lake City; the Department of Psychiatry, State University of New York Upstate Medical University, Syracuse; and the Department of Psychiatry, Rush University Medical Center, Chicago. ·Am J Psychiatry · Pubmed #28359201.

ABSTRACT: OBJECTIVE: The Treatment-Resistant Depression Registry investigated whether adjunctive vagus nerve stimulation (VNS) with treatment as usual in depression has superior long-term outcomes compared with treatment as usual only. METHOD: This 5-year, prospective, open-label, nonrandomized, observational registry study was conducted at 61 U.S. sites and included 795 patients who were experiencing a major depressive episode (unipolar or bipolar depression) of at least 2 years' duration or had three or more depressive episodes (including the current episode), and who had failed four or more depression treatments (including ECT). Patients with a history of psychosis or rapid-cycling bipolar disorder were excluded. The primary efficacy measure was response rate, defined as a decrease of ≥50% in baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score at any postbaseline visit during the 5-year study. Secondary efficacy measures included remission. RESULTS: Patients had chronic moderate to severe depression at baseline (the mean MADRS score was 29.3 [SD=6.9] for the treatment-as-usual group and 33.1 [SD=7.0] for the adjunctive VNS group). The registry results indicate that the adjunctive VNS group had better clinical outcomes than the treatment-as-usual group, including a significantly higher 5-year cumulative response rate (67.6% compared with 40.9%) and a significantly higher remission rate (cumulative first-time remitters, 43.3% compared with 25.7%). A subanalysis demonstrated that among patients with a history of response to ECT, those in the adjunctive VNS group had a significantly higher 5-year cumulative response rate than those in the treatment-as-usual group (71.3% compared with 56.9%). A similar significant response differential was observed among ECT nonresponders (59.6% compared with 34.1%). CONCLUSIONS: This registry represents the longest and largest naturalistic study of efficacy outcomes in treatment-resistant depression, and it provides additional evidence that adjunctive VNS has enhanced antidepressant effects compared with treatment as usual in this severely ill patient population.

5 Article Long-term efficacy, safety, and tolerability of L-methylfolate calcium 15 mg as adjunctive therapy with selective serotonin reuptake inhibitors: a 12-month, open-label study following a placebo-controlled acute study. 2016

Zajecka, John M / Fava, Maurizio / Shelton, Richard C / Barrentine, Lori W / Young, Page / Papakostas, George I. ·1700 Van Buren St, 5th Fl, Chicago, IL 60612 john_zajecka@rush.edu. ·J Clin Psychiatry · Pubmed #27035404.

ABSTRACT: OBJECTIVE: To evaluate remission and recovery, safety, and tolerability for up to 12 months of open-label adjunctive L-methylfolate calcium 15 mg. METHOD: Subjects in this analysis were adult outpatients (18-65 years) enrolled from 2 acute, double-blind, placebo-controlled trials comparing adjunctive L-methylfolate and placebo for DSM-IV major depressive disorder (MDD) with an inadequate response to monotherapy selective serotonin reuptake inhibitor (SSRI). Subjects who completed the acute trial were offered to enroll in a 12-month, open-label treatment phase with L-methylfolate and continued SSRI treatment, with scheduled visits for efficacy, safety, and tolerability every 12 weeks. Subjects were enrolled between September 2006 and February 2010. Efficacy outcomes included predefined criteria for response, remission, recovery, relapse, and recurrence. Subjects treated with adjunctive L-methylfolate 15 mg were included in the efficacy analysis. RESULTS: Of 68 subjects who met criteria for the 12-month open-label phase, 38% (n = 26) achieved full recovery, and none experienced a recurrence of MDD. For subjects entering the open-label phase in remission (n = 11), 91% (n = 10) achieved full recovery with L-methylfolate 15 mg, and none experienced a relapse or recurrence. Among 57 subjects who entered the open-label phase as nonremitted, 61% (n = 35) achieved remission. Of subjects who entered the open-label phase with a response without remission (n = 4), 50% (n = 2) had full recovery, and of subjects entering the open-label phase with no response (n = 53), 26% (n = 14) met recovery criteria. CONCLUSIONS: Adjunctive L-methylfolate 15 mg/d may be an early option in patients who fail to adequately respond to antidepressant monotherapy, with preliminary evidence demonstrating sustained remission and sustained recovery. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00321152.

6 Article Association of obesity and inflammatory marker levels on treatment outcome: results from a double-blind, randomized study of adjunctive L-methylfolate calcium in patients with MDD who are inadequate responders to SSRIs. 2015

Shelton, Richard C / Pencina, Michael J / Barrentine, Lori W / Ruiz, Juan A / Fava, Maurizio / Zajecka, John M / Papakostas, George I. ·Department of Psychiatry and Behavioral Neurobiology, The University of Alabama at Birmingham, 1713 6th Ave S, Birmingham, AL 35294 rshelton@uab.edu. ·J Clin Psychiatry · Pubmed #26613389.

ABSTRACT: OBJECTIVE: Adjunctive treatment with L-methylfolate calcium significantly improved treatment outcomes in patients with major depressive disorder (MDD) and an inadequate response to antidepressants. This post hoc exploratory analysis evaluated baseline concentrations of cytokines (interleukin [IL]-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, and IL-17; tumor necrosis factor α [TNF-α]; and interferon γ [IFN-γ]), high-sensitivity C-reactive protein (hsCRP), insulin, adiponectin and leptin and body mass index (BMI [kg/m2]) on L-methylfolate calcium treatment response. METHOD: Adults with DSM-IV MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) were eligible. Patients were randomized 3:3:2 according to the sequential parallel comparison design to placebo versus placebo, placebo versus L-methylfolate calcium (15 mg/d), or L-methylfolate calcium versus L-methylfolate calcium (15 mg/d) during two 30-day phases. The primary outcome was change on the 17-item Hamilton Depression Rating Scale (HDRS-17). Treatment effect with 95% CIs was estimated from baseline concentrations of individual biomarkers and combinations. Cytokines were measured by immunoassay; adiponectin, insulin, and leptin by radioimmunoassay; and hsCRP by a standard turbidimetric assay. The effects of baseline biomarker levels (above and below the median) on outcome were analyzed. The first participant was enrolled July 14, 2009, and the last participant completed April 28, 2011. RESULTS: Mean change on HDRS-17 from baseline was significantly improved with L-methylfolate calcium versus placebo (pooled treatment effect, -2.74; 95% CI, -4.99 to -0.48; P = .017) overall and for those with baseline BMI ≥ 30 (pooled treatment effect, -4.66; 95% CI, -7.22 to -1.98; P = .001) but not BMI < 30. Pooled mean changes in depression across treatment for baseline levels of individual markers above median were significant (L-methylfolate calcium vs placebo) for TNF-α, IL-8, hsCRP, and leptin (pooled treatment effects, -4.33 to -3.94 [P ≤ .02]) and for combinations of BMI ≥ 30 with elevated levels of TNF-α, IL-6, IL-8, hsCRP, and leptin (pooled treatment effects, -6.31 to -3.98 [P ≤ .05]). CONCLUSIONS: In this exploratory analysis, inflammatory and obesity-related factors were associated with greater symptom improvement with L-methylfolate calcium. Combinations of BMI ≥ 30 with elevated IL-6, IL-8, hsCRP, TNF-α, and leptin predicted improved response to L-methylfolate calcium in MDD patients with an inadequate antidepressant response. Further studies are necessary to confirm these findings. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00955955.

7 Article The pro-inflammatory profile of depressed patients is (partly) related to obesity. 2015

Shelton, Richard C / Falola, Michael / Li, Li / Zajecka, John / Fava, Maurizio / Papakostas, George I. ·Department of Psychiatry, The University of Alabama, Birmingham, AL, USA. Electronic address: rshelton@uab.edu. · Department of Psychiatry, The University of Alabama, Birmingham, AL, USA. · Department of Psychiatry, Rush Medical Center, 1700 W. Van Buren Street, 5th Floor, Chicago, IL, 60612, USA. · Department of Psychiatry and the Clinical Trials Network and Institute (CTNI), Massachusetts General Hospital, 15 Parkman St, Boston, MA, 02114, USA. ·J Psychiatr Res · Pubmed #26424427.

ABSTRACT: Many people with major depressive disorder (MDD) show evidence of systemic inflammation, including elevations in inflammatory factors, but the cause is unclear. The purpose of this analysis was to determine if obesity might contribute to the pro-inflammatory state in MDD patients. Blood was obtained from 135 MDD patients and 50 controls. Serum was extracted and assayed for interleukin (IL) -1β, IL-2, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, interferon-γ (IFNγ), tumor necrosis factor α (TNFα), C-reactive protein (CRP), leptin, and adiponectin using single- or multi-plex human immunoassay kits. The primary analysis contrasted IL-6, TNFα, and CRP between MDD and control groups with body mass index (BMI) as a covariate. The other analytes were compared in an exploratory fashion. IL-6 (but not TNFα or CRP) showed significant differences between MDD and controls even after covarying for BMI. Obese controls and obese MDD groups were significantly higher in IL-6 than both lean groups, but the two obese groups did not differ from each other. In the exploratory analyses, the IL-2 level showed robust and significant differences between MDD and controls even after covarying for BMI. Both lean and obese MDD were higher than lean and obese controls. Adiponectin levels were also lower in the MDD sample than controls. Prior findings of higher IL-6, and CRP in MDD patients may be explained, at least in part, based on obesity. High IL-2, however, was associated with depression and not obesity. The results have significant implications for the understanding of pathophysiology and, potentially treatment of MDD.

8 Article A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, Flexible-Dose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder. 2015

Mahableshwarkar, Atul R / Zajecka, John / Jacobson, William / Chen, Yinzhong / Keefe, Richard S E. ·Takeda Development Center Americas, Deerfield, IL, USA. · Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA. · Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA. ·Neuropsychopharmacology · Pubmed #25687662.

ABSTRACT: This multicenter, randomized, double-blind, placebo-controlled, active-referenced (duloxetine 60 mg), parallel-group study evaluated the short-term efficacy and safety of vortioxetine (10-20 mg) on cognitive function in adults (aged 18-65 years) diagnosed with major depressive disorder (MDD) who self-reported cognitive dysfunction. Efficacy was evaluated using ANCOVA for the change from baseline to week 8 in the digit symbol substitution test (DSST)-number of correct symbols as the prespecified primary end point. The patient-reported perceived deficits questionnaire (PDQ) and physician-assessed clinical global impression (CGI) were analyzed in a prespecified hierarchical testing sequence as key secondary end points. Additional predefined end points included the objective performance-based University of San Diego performance-based skills assessment (UPSA) (ANCOVA) to measure functionality, MADRS (MMRM) to assess efficacy in depression, and a prespecified multiple regression analysis (path analysis) to calculate direct vs indirect effects of vortioxetine on cognitive function. Safety and tolerability were assessed at all visits. Vortioxetine was statistically superior to placebo on the DSST (P < 0.05), PDQ (P < 0.01), CGI-I (P < 0.001), MADRS (P < 0.05), and UPSA (P < 0.001). Path analysis indicated that vortioxetine's cognitive benefit was primarily a direct treatment effect rather than due to alleviation of depressive symptoms. Duloxetine was not significantly different from placebo on the DSST or UPSA, but was superior to placebo on the PDQ, CGI-I, and MADRS. Common adverse events (incidence ⩾ 5%) for vortioxetine were nausea, headache, and diarrhea. In this study of MDD adults who self-reported cognitive dysfunction, vortioxetine significantly improved cognitive function, depression, and functionality and was generally well tolerated.

9 Article Effect of adjunctive L-methylfolate 15 mg among inadequate responders to SSRIs in depressed patients who were stratified by biomarker levels and genotype: results from a randomized clinical trial. 2014

Papakostas, George I / Shelton, Richard C / Zajecka, John M / Bottiglieri, Teodoro / Roffman, Joshua / Cassiello, Clair / Stahl, Stephen M / Fava, Maurizio. ·Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, One Bowdoin Sq, 6th Fl, Boston, MA 02114 gpapakostas@partners.org. ·J Clin Psychiatry · Pubmed #24813065.

ABSTRACT: OBJECTIVE: Specific genetic or biological markers may predict inadequate response to therapy for major depressive disorder (MDD). The objective of the current post hoc analysis was to evaluate the effect of specific biological and genetic markers on the antidepressant efficacy of adjunctive L-methylfolate 15 mg versus placebo from a trial of inadequate responders to selective serotonin reuptake inhibitors (SSRIs). METHOD: The double-blind, randomized, placebo-controlled trial used the sequential parallel comparison design. Outpatients with SSRI-resistant MDD (DSM-IV criteria) received L-methylfolate 15 mg/d for 60 days, placebo for 30 days followed by L-methylfolate 15 mg/d for 30 days, or placebo for 60 days. The effects of baseline levels of select biological and genetic markers individually and combined on treatment response to L-methylfolate versus placebo were evaluated; the primary response measure was the 28-Item Hamilton Depression Rating Scale (HDRS-28). The first patient was enrolled July 14, 2009, and the last patient completed April 28, 2011. RESULTS: Seventy-five patients were enrolled. Patients with specific biological (body mass index ≥ 30 kg/m², elevated plasma levels of high-sensitivity C-reactive protein or 4-hydroxy-2-nonenal, low S-adenosylmethionine/S-adenosylhomocysteine ratio) and genetic markers at baseline had significantly (P ≤ .05) greater pooled mean change from baseline on the HDRS-28 with L-methylfolate versus placebo. Pooled mean change from baseline on the Clinical Global Impressions-Severity of Illness scale was significantly (P < .05) greater with L-methylfolate versus placebo for most genetic markers. Most combinations of baseline biological and genetic markers predicted significantly (P ≤ .05) greater reductions in pooled mean change from baseline in HDRS-28 scores with L-methylfolate versus placebo. CONCLUSIONS: Biomarkers associated with inflammation or metabolism and genomic markers associated with L-methylfolate synthesis and metabolism may identify patients with SSRI-resistant depression who are responsive to adjunctive therapy with L-methylfolate 15 mg. Confirmatory studies are needed. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00955955.

10 Article A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. 2012

Papakostas, George I / Vitolo, Ottavio V / Ishak, Waguih W / Rapaport, Mark H / Zajecka, John M / Kinrys, Gustavo / Mischoulon, David / Lipkin, Samuel H / Hails, Katherine A / Abrams, Jonah / Ward, Sean G / Meisner, Allison / Schoenfeld, David A / Shelton, Richard C / Winokur, Andrew / Okasha, Mahmoud S / Bari, Mohammed A / Fava, Maurizio. ·Center for Treatment-Resistant Depression, Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. gpapakostas@partners.org ·J Clin Psychiatry · Pubmed #23290327.

ABSTRACT: OBJECTIVE: To study ziprasidone monotherapy for major depressive disorder, defined according to the DSM-IV. METHOD: One hundred twenty outpatients were enrolled between June 2008 and September 2010 in a 12-week study that was divided into two 6-week periods according to the sequential parallel comparison design. Patients were randomized in a 2:3:3 fashion to receive ziprasidone for 12 weeks, placebo for 6 weeks followed by ziprasidone for 6 weeks, or placebo for 12 weeks. The main outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS-17), with the Quick Inventory of Depressive Symptomatology, Self-Rated (QIDS-SR), and Clinical Global Impressions-Severity of Illness scale (CGI-S) serving as the study secondary measures. RESULTS: One hundred twenty patients (53 women [44.1%]) were randomized to treatment. The mean (SD) age of these patients was 43.7 (11.0) years. Mean (SD) baseline HDRS-17, CGI-S, and QIDS-SR scores were 19.9 (5.0), 4.3 (0.6), and 15.6 (3.0), respectively. There was no statistically significant difference in reduction of depressive symptoms, response rates, or remission rates between ziprasidone- or placebo-treated patients. This was true for both the study primary as well as secondary outcome scales. CONCLUSIONS: In conclusion, treatment with ziprasidone monotherapy was not associated with any statistically significant advantage in efficacy over placebo. Although studies involving larger sample size would be required to have adequate statistical power to detect treatment differences smaller than 2.5 points on the HDRS-17, such differences would be of questionable clinical relevance. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00555997.

11 Article L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials. 2012

Papakostas, George I / Shelton, Richard C / Zajecka, John M / Etemad, Bijan / Rickels, Karl / Clain, Alisabet / Baer, Lee / Dalton, Elizabeth D / Sacco, Garret R / Schoenfeld, David / Pencina, Michael / Meisner, Allison / Bottiglieri, Teodoro / Nelson, Erik / Mischoulon, David / Alpert, Jonathan E / Barbee, James G / Zisook, Sidney / Fava, Maurizio. ·Center for Treatment-Resistant Depression, Depression Clinical and Research Program, the Biostatistics Center, and the Clinical Trials Network and Institute, Massachusetts General Hospital, Boston, MA, USA. gpapakostas@partners.org ·Am J Psychiatry · Pubmed #23212058.

ABSTRACT: OBJECTIVE: The authors conducted two multicenter sequential parallel comparison design trials to investigate the effect of L-methylfolate augmentation in the treatment of major depressive disorder in patients who had a partial response or no response to selective serotonin reuptake inhibitors (SSRIs). METHOD: In the first trial, 148 outpatients with SSRI-resistant major depressive disorder were enrolled in a 60-day study divided into two 30-day periods. Patients were randomly assigned, in a 2:3:3 ratio, to receive L-methylfolate for 60 days (7.5 mg/day for 30 days followed by 15 mg/day for 30 days), placebo for 30 days followed by L-methylfolate (7.5 mg/day) for 30 days, or placebo for 60 days. SSRI dosages were kept constant throughout the study. In the second trial, with 75 patients, the design was identical to the first, except that the l-methylfolate dosage was 15 mg/day during both 30-day periods. RESULTS: In the first trial, no significant difference was observed in outcomes between the treatment groups. In the second trial, adjunctive L-methylfolate at 15 mg/day showed significantly greater efficacy compared with continued SSRI therapy plus placebo on both primary outcome measures (response rate and degree of change in depression symptom score) and two secondary outcome measures of symptom severity. The number needed to treat for response was approximately six in favor of adjunctive L-methylfolate at 15 mg/day. L-Methylfolate was well tolerated, with rates of adverse events no different from those reported with placebo. CONCLUSIONS: Adjunctive L-methylfolate at 15 mg/day may constitute an effective, safe, and relatively well tolerated treatment strategy for patients with major depressive disorder who have a partial response or no response to SSRIs.

12 Unspecified Evidence for the use of l-methylfolate combined with antidepressants in MDD. 2011

Fava, Maurizio / Shelton, Richard C / Zajecka, John M. ·From the Department of Psychiatry, Harvard Medical School and Massachusetts General Hospital, Boston, USA. ·J Clin Psychiatry · Pubmed #21899813.

ABSTRACT: Helping patients with major depressive disorder achieve symptom-free remission with antidepressant therapy remains challenging. In this activity, 3 investigators discuss the results of a 2-trial, multicenter, randomized, double-blind, placebo-controlled study of adjunctive l-methylfolate, the bioavailable form of folate, in patients who had inadequately responded to an SSRI. The efficacy of doses of 7.5 mg/d versus 15 mg/d is examined, and the safety and tolerability of l-methylfolate are compared with those of other adjunctive treatments. Different types of folate are explained, and the characteristics of patients who might benefit from adjunctive l-methylfolate are proposed.

13 Retraction Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. 2014

Hollon, Steven D / DeRubeis, Robert J / Fawcett, Jan / Amsterdam, Jay D / Shelton, Richard C / Zajecka, John / Young, Paula R / Gallop, Robert. ·Department of Psychology, Vanderbilt University, Nashville, Tennessee. · Department of Psychology, University of Pennsylvania, Philadelphia. · Department of Psychiatry, University of New Mexico, Albuquerque. · Department of Psychiatry, University of Pennsylvania, Philadelphia. · Department of Psychiatry, Vanderbilt University, Nashville, Tennessee6currently at the Department of Psychiatry, University of Alabama, Birmingham. · Department of Psychiatry, Rush University, Chicago, Illinois. · Department of Mathematics and Applied Statistics, West Chester University, West Chester, Pennsylvania. ·JAMA Psychiatry · Pubmed #25142196.

ABSTRACT: IMPORTANCE: Antidepressant medication (ADM) is efficacious in the treatment of depression, but not all patients achieve remission and fewer still achieve recovery with ADM alone. OBJECTIVE: To determine the effects of combining cognitive therapy (CT) with ADM vs ADM alone on remission and recovery in major depressive disorder (MDD). DESIGN, SETTING, AND PARTICIPANTS: A total of 452 adult outpatients with chronic or recurrent MDD participated in a trial conducted in research clinics at 3 university medical centers in the United States. The patients were randomly assigned to ADM treatment alone or CT combined with ADM treatment. Treatment was continued for up to 42 months until recovery was achieved. INTERVENTIONS: Antidepressant medication with or without CT. MAIN OUTCOMES AND MEASURES: Blind evaluations of recovery with a modified version of the 17-item Hamilton Rating Scale for Depression and the Longitudinal Interval Follow-up Evaluation. RESULTS: Combined treatment enhanced the rate of recovery vs treatment with ADM alone (72.6% vs 62.5%; t451 = 2.45; P = .01; hazard ratio [HR], 1.33; 95% CI, 1.06-1.68; number needed to treat [NNT], 10; 95% CI, 5-72). This effect was conditioned on interactions with severity (t451 = 1.97; P = .05; NNT, 5) and chronicity (χ2 = 7.46; P = .02; NNT, 6) such that the advantage for combined treatment was limited to patients with severe, nonchronic MDD (81.3% vs 51.7%; n = 146; t145 = 3.96; P = .001; HR, 2.34; 95% CI, 1.54-3.57; NNT, 3; 95% CI, 2-5). Fewer patients dropped out of combined treatment vs ADM treatment alone (18.9% vs 26.8%; t451 = -2.04; P = .04; HR, 0.66; 95% CI, 0.45-0.98). Remission rates did not differ significantly either as a main effect of treatment or as an interaction with severity or chronicity. Patients with comorbid Axis II disorders took longer to recover than did patients without comorbid Axis II disorders regardless of the condition (P = .01). Patients who received combined treatment reported fewer serious adverse events than did patients who received ADMs alone (49 vs 71; P = .02), largely because they experienced less time in an MDD episode. CONCLUSIONS AND RELEVANCE: Cognitive therapy combined with ADM treatment enhances the rates of recovery from MDD relative to ADMs alone, with the effect limited to patients with severe, nonchronic depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00057577.