Browsing by Author "Trivedi, Madhukar H"
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Item Open Access A Structured Approach to Detecting and Treating Depression in Primary Care: VitalSign6 Project.(Annals of family medicine, 2019-07) Jha, Manish K; Grannemann, Bruce D; Trombello, Joseph M; Clark, E Will; Eidelman, Sara Levinson; Lawson, Tiffany; Greer, Tracy L; Rush, A John; Trivedi, Madhukar HPurpose
This report describes outcomes of an ongoing quality-improvement project (VitalSign6) in a large US metropolitan area to improve recognition, treatment, and outcomes of depressed patients in 16 primary care clinics (6 charity clinics, 6 federally qualified health care centers, 2 private clinics serving low-income populations, and 2 private clinics serving patients with either Medicare or private insurance).Methods
Inclusion in this retrospective analysis was restricted to the first 25,000 patients (aged ≥12 years) screened with the 2-item Patient Health Questionnaire (PHQ-2) in the aforementioned quality-improvement project. Further evaluations with self-reports and clinician assessments were recorded for those with positive screen (PHQ-2 >2). Data collected from August 2014 though November 2016 were available at 3 levels: (1) initial PHQ-2 (n = 25,000), (2) positive screen (n = 4,325), and (3) clinician-diagnosed depressive disorder with 18 or more weeks of enrollment (n = 2,160).Results
Overall, 17.3% (4,325/25,000) of patients screened positive for depression. Of positive screens, 56.1% (2,426/4,325) had clinician-diagnosed depressive disorder. Of those enrolled for 18 or more weeks, 64.8% were started on measurement-based pharmacotherapy and 8.9% referred externally. Of the 1,400 patients started on pharmacotherapy, 45.5%, 30.2%, 12.6%, and 11.6% had 0, 1, 2, and 3 or more follow-up visits, respectively. Remission rates were 20.3% (86/423), 31.6% (56/177), and 41.7% (68/163) for those with 1, 2, and 3 or more follow-up visits, respectively. Baseline characteristics associated with higher attrition were: non-white, positive drug-abuse screen, lower depression/anxiety symptom severity, and younger age.Conclusion
Although remission rates are high in those with 3 or more follow-up visits after routine screening and treatment of depression, attrition from care is a significant issue adversely affecting outcomes.Item Open Access Bupropion and Naltrexone in Methamphetamine Use Disorder.(The New England journal of medicine, 2021-01) Trivedi, Madhukar H; Walker, Robrina; Ling, Walter; Dela Cruz, Adriane; Sharma, Gaurav; Carmody, Thomas; Ghitza, Udi E; Wahle, Aimee; Kim, Mora; Shores-Wilson, Kathy; Sparenborg, Steven; Coffin, Phillip; Schmitz, Joy; Wiest, Katharina; Bart, Gavin; Sonne, Susan C; Wakhlu, Sidarth; Rush, A John; Nunes, Edward V; Shoptaw, StevenBackground
The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.Methods
We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.Results
A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.Conclusions
Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).Item Open Access Childhood maltreatment and impact on clinical features of major depression in adults.(Psychiatry research, 2020-11) Medeiros, Gustavo C; Prueitt, William L; Minhajuddin, Abu; Patel, Shirali S; Czysz, Andrew H; Furman, Jennifer L; Mason, Brittany L; Rush, A John; Jha, Manish K; Trivedi, Madhukar HObjectives
This study examined: 1) the prevalence of childhood maltreatment (CMT) in individuals with chronic and/or recurrent depression, 2) the association between CMT and depressive symptoms, 3) the link between CMT and worse clinical presentation of depression, 4) the effects of accumulation of different types of CMT, and 5) the relationship between the age at CMT and depression.Methods
We analyzed the baseline data of 663 individuals from the CO-MED study. CMT was determined by a brief self-reported questionnaire assessing sexual abuse, emotional abuse, physical abuse, and neglect. Correlational analyses were conducted.Results
Half of the sample (n = 331) reported CMT. Those with CMT had higher rates of panic/phobic, cognitive and anhedonic symptoms than those without CMT. All individual types of maltreatment were associated with a poorer clinical presentation including: 1) earlier MDD onset; 2) more severe MDD, 3) more suiccidality, 4) worse quality of life, and functioning, and 5) more psychiatric comorbidities. Clinical presentation was worse in participants who reported multiple types of CMT.Conclusions
In chronic and/or recurrent depression, CMT is common, usually of multiple types and is associated with a worse clinical presentation in MDD. The combination of multiple types of CMT is associated with more impairment.Item Open Access Predicting future suicidal events in adolescents using the Concise Health Risk Tracking Self-Report (CHRT-SR).(Journal of psychiatric research, 2020-07) Mayes, Taryn L; Killian, Michael; Rush, A John; Emslie, Graham J; Carmody, Thomas; Kennard, Betsy D; Jha, Manish K; King, Jessica; Hughes, Jennifer L; Trivedi, Madhukar HBackground
Several self-report rating scales have been developed to assess suicidal ideation, yet most have limited utility in predicting future suicide attempts. This is particularly critical in adolescence, where suicide is the second leading cause of death. This study evaluated the Concise Health Risk Tracking Self-Report (CHRT-SR) as a prospective predictor of suicide attempts and events in high-risk adolescents enrolled in a suicide-prevention intensive outpatient program (IOP).Methods
Data were collected by retrospective chart review of adolescents treated in IOP for youth with severe suicidality. At baseline, youth completed the 14-item CHRT-SR (CHRT-SR14), which assesses suicide risk based on 3 subscales: Propensity, Impulsivity, and Suicidal Thoughts. Two outcomes were assessed: actual suicide attempts and suicidal events (suicide attempt, inpatient hospitalization, or emergency department visit) during the IOP.Results
Of the 251 adolescents who completed the baseline CHRT-SR14, 26 had a suicidal event during IOP (mean time in IOP: 5.4 ± 2.3 weeks), of whom 14 had an actual suicide attempt. Youth with any suicidal event had higher scores than those without an event on the CHRT-SR14 Total (p = .005), Propensity (p = .008), and Suicidal Thoughts (p = .001) scales at baseline. Youth who made a suicide attempt had significantly higher scores than those without an event for the Total Score, Propensity, and Suicidal Thoughts subscales. CHRT-SR14 Total Score of 28 had a sensitivity of 85.7% and specificity of 56.5% in predicting suicide attempts. A score of 22 predicted suicidal events, with a sensitivity of 80.8% and specificity of 40.9%. CHRT-SR7 Total Score of 12 predicted suicide attempts, with a sensitivity of 85.7% and specificity of 53.4%.Conclusions
The CHRT-SR14 self-report predicts suicide attempts and events with at least 80% sensitivity and acceptable specificity in adolescents at high-risk for suicide.Item Open Access Prediction of Acute-Phase Treatment Outcomes by Adding a Single-Item Measure of Activity Impairment to Symptom Measurement: Development and Validation of an Interactive Calculator from the STAR*D and CO-MED Trials.(The international journal of neuropsychopharmacology, 2019-05) Jha, Manish K; South, Charles; Trivedi, Jay; Minhajuddin, Abu; Rush, A John; Trivedi, Madhukar HBackground
Day-to-day functioning is impaired in major depressive disorder. Yet there are no guidelines to systematically assess these functional changes. This report evaluates prognostic utility of changes in activity impairment to inform clinical decision-making at an individual level.Methods
Mixed model analyses tested changes in activity impairment (sixth item of Work and Activity Impairment scale, rated 0-10) at mid-point (week 6) and end of step 1 (weeks 12-14) in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial (n = 2697) after controlling for depression severity [Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR)]. Interactive calculators for end of step 1 remission (QIDS-SR ≤5) and no meaningful benefit (<30% QIDS-SR reduction from baseline) were developed for participants with complete data (n = 1476) and independently replicated in the Combining Medications to Enhance Depression Outcomes trial (n = 399).Results
Activity impairment improved independently with acute-phase treatment in STAR*D (F = 7.27; df = 2,2625; P < .001). Baseline to mid-point activity impairment change significantly predicted remission (P < .001, model area under the curve = 0.823) and no meaningful benefit (P < .001, area under the curve = 0.821) in the STAR*D trial. Adding activity impairment variables to depression severity measures correctly reclassified 28.4% and 15.8% remitters and nonremitters (net reclassification improvement analysis, P < .001), and 11.4% and 16.8% of those with no meaningful benefit and meaningful benefit (net reclassification improvement analysis, P < .001). The STAR*D trial model estimates accurately predicted remission (area under the curve = 0.80) and no meaningful benefit (area under the curve = 0.82) in the Combining Medications to Enhance Depression Outcomes trial and was used to develop an interactive calculator.Conclusion
A single-item self-report measure of activity impairment changes independently with antidepressant treatment. Baseline to week 6 changes in activity impairment and depression severity can be combined to predict acute-phase remission and no meaningful benefit at an individual level.Item Open Access Psychometric and Clinical Evaluation of the Clinician (VQIDS-C5) and Self-Report (VQIDS-SR5) Versions of the Very Quick Inventory of Depressive Symptoms.(Neuropsychiatric disease and treatment, 2022-01) Rush, A John; Madia, Nancy D; Carmody, Thomas; Trivedi, Madhukar HPurpose
Evaluate the psychometric properties of the 5-item Very Quick Inventory of Depressive Symptomatology self-report and clinician-rated versions (VQIDS-SR5/VQIDS-C5), compare their relative performance, create crosswalks between their total scores and other accepted depressive symptom ratings, and define clinically relevant depressive symptom severity thresholds and categorical outcomes for both versions.Patients and methods
The Sequenced Treatment Alternatives to Relieve Depression trial obtained baseline and exit 17-item Hamilton Rating Scale for Depression (HRSD17) and 30-item Inventory of Depressive Symptomatology - Clinician-rated scores, and baseline and visit-wise QIDS-SR16 and QIDS-C16 ratings from the first treatment step (citalopram). The VQIDS-C5 and the VQIDS-SR5 items (sad mood, self-outlook, involvement, fatigue, psychomotor slowing) (each rated 0-3), extracted from the corresponding 16-item ratings, were selected to best reflect the 6-item HRSD (HRSD6) (exclusive of anxiety). Classical Test Theory (CTT) and Item-Response Theory (IRT) analyses assessed psychometric features. IRT analyses produced total score crosswalks between the VQIDS5, QIDS-C16, QIDS-SR16 and HRSD6. Clinically relevant VQIDS symptom severity thresholds and treatment outcomes were estimated based on cross-walks from the parent QIDS16 ratings.Results
Both VQIDS versions were unifactorial with acceptable internal consistencies (Cronbach's alphas >0.80), item-total correlations (0.57-0.74) by CCT, and strong IRT item performance. Based on QIDS16 severity thresholds (none 0-5; mild 6-10; moderate 11-15; severe 16-20; and very severe 21-27), comparable thresholds were 0-2; 3-5; 6-9; 9-12; and >12 for VQIDS-C5, and 0-2; 2-5; 6-8; 9-12; and >12 for VQIDS-SR5. Kappa values were acceptable in comparing categories of outcomes (eg, no benefit, remission, etc) based on VQIDS and corresponding QIDS categories.Conclusion
The VQIDS-C5 and VQIDS-SR5 assess selected core depressive symptoms with psychometrically acceptable properties. Theelf-report and clinician-rated versions provide virtually identical information, symptom severity thresholds and symptom change categories. Both are as sensitive to change as the corresponding QIDS16, making them suitable for use in busy practices.Item Open Access The Adolescent Resilience Questionnaire: Validation of a Shortened Version in U.S. Youths.(Frontiers in psychology, 2020-01) Anderson, Jacqueline R; Killian, Michael; Hughes, Jennifer L; Rush, A John; Trivedi, Madhukar HIntroduction
Resilience is a factor in how youth respond to adversity. The 88-item Adolescent Resilience Questionnaire is a comprehensive, multi-dimensional self-report measure of resilience developed with Australian youth.Methods
Using a cross-sectional adolescent population (n = 3,222), confirmatory factor analysis was conducted to replicate the original factor structure. Over half of the adolescents were non-white and 9th graders with a mean age of 15.5.Results
Our exploratory factor analysis shortened the measure for which we conducted the psychometric analyses. The original factor structure was not replicated. The exploratory factor analysis provided a 49-item measure. Internal consistency reliability for all 12 factors ranged from acceptable (α> 0.70-0.80). The revised factor total scores were highly and significantly correlated with item-total correlation coefficients (r > 0.63, p < 0.001).Conclusion
This revised shorter 49-item version of the Adolescent Resilience Questionnaire could be deployed and has acceptable psychometric properties.Item Open Access What to Expect When Switching to a Second Antidepressant Medication Following an Ineffective Initial SSRI: A Report From the Randomized Clinical STAR*D Study.(The Journal of clinical psychiatry, 2020-08-11) Rush, A John; South, Charles; Jha, Manish K; Jain, Shailesh Bobby; Trivedi, Madhukar HOBJECTIVE:An antidepressant medication switch often follows a failed initial trial with selective serotonin reuptake inhibitors (SSRIs). When, for whom, and how often second-step response and remission occur are unclear, as is preferred second-step trial duration. As more treatments are approved for use following 2 failed "adequate" trials, researchers and clinicians require an evidence-based definition of "adequate." METHODS:Following citalopram in the randomized Sequenced Treatment Alternatives to Relieve Depression (STAR*D) clinical trial (which ran July 2001-September 2006), participants with score ≥ 11 on the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR₁₆) were randomized to bupropion sustained release, sertraline, or venlafaxine extended release (up to 14 weeks). The QIDS-SR₁₆ defined response, remission, and no clinically meaningful benefit based on the modified intent-to-treat sample. RESULTS:About 80% of 438 participants completed ≥ 6 weeks of treatment with the switch medication. All treatments had comparable outcomes. Overall, 21% (91/438) remitted, 9% (40/438) responded without remission, and 58% (255/438) had no meaningful benefit. Half of the responses and two-thirds of remissions occurred after 6 weeks of treatment. Overall, 33% of responses (43/131) occurred after ≥ 9 weeks of treatment. No baseline features differentiated early from later responders or remitters. No early triage point was found, but those with at least 20% reduction from baseline in QIDS-SR₁₆ score around week 2 were 6 times more likely to respond or remit than those without this reduction. CONCLUSIONS:Following nonefficacy with an initial SSRI, only about 20% remit and more than half achieve no meaningful benefit with a second-step switch to another monoaminergic antidepressant. A 12-week trial duration seems necessary to capture as many second-step switch responders as possible. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT00021528.