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Biomedical subjects

Mustafa M Husain

Publications and source records attributed to Mustafa M Husain.

At least 19 recordsLinked to original sources

Clinical differences among depressed patients with and without a history of suicide attempts: findings from the STAR*D trial.

BACKGROUND: This study sought to determine whether a history of suicide attempts among outpatients diagnosed with nonpsychotic major depressive disorder (MDD) is correlated with any difference in clinical presentation that should influence patient care. METHODS: Baseline data from the Sequenced Treatment Alternatives to Relieve Depression (STAR()D) trial on outpatients with MDD treated in primary and specialty care settings were used to model significant demographic and clinical correlates of suicide attempter status. RESULTS: Altogether, 16.5% of participants (n=667) reported prior suicide attempts. Controlling for age, gender, and depressive symptom severity, previous attempters had more current general medical conditions (micro=3.2 vs. 2.9, p<.0001), more current alcohol/substance abuse (p<.0001), and more work hours missed in the past week (26.2% vs. 18.2%, p<.0001) than non-attempters. On average, for the previously suicidal, the onset of MDD occurred 8.9 years earlier in life (p<.0001) and had included 1.2 additional depressive episodes (p=0.001) compared to those without prior suicidal behavior. Previous attempters also reported more current suicidal ideation (61.3% of previous attempters, adjusted OR 1.6, vs. 45.5% of nonattempters, p<.0001). LIMITATIONS: Presence or absence of a history of suicide attempts was determined only through self report. CONCLUSIONS: Those with a history of suicidal behavior suffer a greater burden of depressive illness. Earlier intervention and ongoing, aggressive care, including maintenance-phase pharmacotherapy, may be critical to mitigating the long-term consequences associated with this increased disease burden.

Absenteeism↗

Making clinicians lives easier: guidance on use of the QIDS self-report in place of the MADRS.

BACKGROUND: The ability to convert total scores from one scale to another facilitates the interpretation of research findings and facilitates the use of systematic measurement in clinical practice. METHODS: Item Response Theory methods were used to convert total scores between the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16) and the Montgomery Asberg Depression Rating Scale (MADRS) total scores. Data were obtained from a sample of 233 outpatients with highly treatment-resistant, nonpsychotic major depressive episodes participating in a one-year open label study of vagus nerve stimulation to augment psychotropic medication treatment. RESULTS: MADRS total scores averaged 31.9 (SD = 6.7) at baseline and 21.9 (SD = 11.0) at one year. QIDS-SR16 total scores averaged 17.6 (SD = 3.6) at baseline and 12.5 (SD = 5.8) at one year. Based on one-year data (or exit if the patient did not complete one year), corresponding QIDS-SR16 and MADRS total scores were presented for each possible QIDS-SR16 and MADRS total score. A QIDS-SR16 total score of 5 was comparable to a MADRS total score of 7 or 8 (7.5). LIMITATION: The degree to which these results generalize to less treatment-resistant samples is unknown. CONCLUSION: The conversion of QIDS-SR16 and MADRS total scores provides a basis for clinicians who wish to use the QIDS-SR16 to understand what MADRS total scores reported in clinical trials approximate QIDS-SR16 total scores obtained with their patients.

Adult↗

Enrolling research subjects from clinical practice: ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4,041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.

Adolescent↗

Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE).

BACKGROUND: Although electroconvulsive therapy (ECT) has been shown to be extremely effective for the acute treatment of major depression, it has never been systematically assessed as a strategy for relapse prevention. OBJECTIVE: To evaluate the comparative efficacy of continuation ECT (C-ECT) and the combination of lithium carbonate plus nortriptyline hydrochloride (C-Pharm) in the prevention of depressive relapse. DESIGN: Multisite, randomized, parallel design, 6-month trial performed from 1997 to 2004. SETTING: Five academic medical centers and their outpatient psychiatry clinics. PATIENTS: Two hundred one patients with Structured Clinical Interview for DSM-IV-diagnosed unipolar depression who had remitted with a course of bilateral ECT. INTERVENTIONS: Random assignment to 2 treatment groups receiving either C-ECT (10 treatments) or C-Pharm for 6 months. MAIN OUTCOME MEASURE: Relapse of depression, compared between the C-ECT and C-Pharm groups. RESULTS: In the C-ECT group, 37.1% experienced disease relapse, 46.1% continued to have disease remission at the study end, and 16.8% dropped out of the study. In the C-Pharm group, 31.6% experienced disease relapse, 46.3% continued to have disease remission, and 22.1% dropped out of the study. Both Kaplan-Meier and Cox proportional hazards regression analyses indicated no statistically significant differences in overall survival curves and time to relapse for the groups. Mean +/- SD time to relapse for the C-ECT group was 9.1 +/- 7.0 weeks compared with 6.7 +/- 4.6 weeks for the C-Pharm group (P = .13). Both groups had relapse proportions significantly lower than a historical placebo control from a similarly designed study. CONCLUSIONS: Both C-ECT and C-Pharm were shown to be superior to a historical placebo control, but both had limited efficacy, with more than half of patients either experiencing disease relapse or dropping out of the study. Even more effective strategies for relapse prevention in mood disorders are urgently needed.

Adolescent↗

Patterns of psychotropic medication use among patients with severe depression referred for electroconvulsive therapy: data from the Consortium for Research on Electroconvulsive Therapy.

Most studies of trends in antidepressant pharmacotherapy have focused on relatively mildly ill, nonpyschotic outpatients. In this report, we provide detailed information on psychotropic use among patients with unipolar depression participating in a large, multisite electroconculsive therapy (ECT) study. Adequacy of antidepressant medication trials was assessed with the Antidepressant Treatment History Form. Among patients with nonpsychotic depression, 27% (60/220) had not had an adequate trial of an antidepressant before ECT, and 63% (139/220) had had at least one inadequate trial. Surprisingly, 33% (79/243) of nonpsychotic patients had been prescribed an antipsychotic. Among patients with psychotic depression, 95% (101/106) had not been given an adequate combination of an antidepressant and antipsychotic agent, mostly due to low doses of the latter class. Among all patients in the trial, 61% (213/352) had been prescribed at least one benzodiazepine, and only 7% (24/352) had been given a lithium augmentation trial. Use of hypnotic agents and anticonvulsants was common. In conclusion, patients with severe depression referred for ECT with a unipolar depressive episode have high rates of psychotropic usage, much of which is inadequate.

Adolescent↗

Concomitant use of vagus nerve stimulation and electroconvulsive therapy for treatment-resistant depression.

OBJECTIVE: This study explored the use of electroconvulsive therapy (ECT) in the pivotal study of vagus nerve stimulation (VNS) for treatment-resistant depression. METHODS: The clinical characteristics and outcomes of study participants who received ECT during the first 12 months of VNS were compared with those who did not receive ECT. Physicians were instructed to turn off VNS during administration of ECT. RESULTS: Of 205 (evaluable sample) patients who received VNS, 14 also received ECT. Participants who received ECT had a statistically significant greater number of hospital admissions (P = 0.037, Wilcoxon) and number of suicide attempts during their lifetimes (P= 0.022, Fisher exact test). Of 55 responders (> or =50% reduction in Hamilton Rating Scale for Depression-24 questions [HRSD-24] scores) after 12 months of VNS, 3 had received ECT. Of 32 remitters (HRSD-24 score, < or =9), 2 had received ECT. Administration of ECT did not affect the implanted VNS device, and the presence of the implanted VNS device did not affect the administration of ECT. CONCLUSIONS: Electroconvulsive therapy and VNS are not mutually exclusive. They can be used safely and effectively either sequentially or concurrently. Each can be prescribed as the depressive condition warrants-ECT for emergently worsening depressive symptoms and maintenance therapy and VNS for chronic, long-term therapy.

Adult↗

Anesthetic considerations for magnetic seizure therapy: a novel therapy for severe depression.

Electroconvulsive therapy (ECT) is a highly effective treatment for severe depression. However, its use is associated with significant posttreatment cognitive impairment. Magnetic seizure therapy (MST) was developed as an alternative therapy that could reduce postseizure side effects through the induction of more "focal" seizure activity. Using an open-parallel study design, we compared 20 case-matched patients undergoing a series of either ECT or MST procedures with respect to their anesthetic, muscle relaxant, and cardiovascular drug requirements, effects on cardiovascular and electroencephalographic bispectral index (BIS) values, and early recovery times. We found that MST was associated with a reduced time to orientation (4 +/- 1 versus 18 +/- 5 min; P < 0.01) compared with ECT. To minimize residual muscle paralysis after MST, a reduction in the succinylcholine dosage (38 +/- 17 versus 97 +/- 2 mg; P < 0.01) was required. The BIS values were higher before, and lower immediately after, the stimulus was applied in the MST (versus ECT) group. The Hamilton depression rating scale score was significantly reduced from the baseline value in both treatment groups; however, the posttreatment score was lower after the series of ECT treatments (6 +/- 6 versus 14 +/- 10; P < 0.05). We conclude that MST was associated with a decreased requirement for muscle relaxants, reduced variability in the BIS values after seizure induction, and a more rapid recovery of cognitive function compared with ECT. Further studies are required to evaluate the antidepressant efficacy of MST versus ECT when they are administered at comparable levels of cerebral stimulation.

Anesthesia↗

Pregnancy and delivery while receiving vagus nerve stimulation for the treatment of major depression: a case report.

BACKGROUND: Depression during pregnancy can have significant health consequences for the mother and her infant. Antidepressant medications, which pass through the placenta, may increase the risk of low birth weight and preterm delivery. The use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy may induce serotonergic symptoms in the infant after delivery. Antidepressant medications in breast milk may also be passed to an infant. Vagus nerve stimulation (VNS) therapy is an effective non-pharmacologic treatment for treatment-resistant depression (TRD), but little information exists regarding the use of VNS therapy during pregnancy. CASE PRESENTATION: The patient began receiving VNS therapy for TRD in March 1999. The therapy was effective, producing substantial reductions in depressive symptoms and improvement of function. In 2002, the patient reported that she was pregnant. She continued receiving VNS therapy throughout her pregnancy, labor, and delivery, which enabled the sustained remission of her depression. The pregnancy was uneventful; a healthy daughter was delivered at full term. CONCLUSION: In this case, VNS therapy provided effective treatment for TRD during pregnancy and delivery. VNS was safe for the patient and her child.

Journal Article↗

Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.

BACKGROUND: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. METHODS: This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n = 210) or nonpsychotic, depressed phase, bipolar disorder (n = 25). In the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sham VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (>/=50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD(24)]). RESULTS: At 10-weeks, HRSD(24) response rates were 15.2% for the active (n = 112) and 10.0% for the sham (n = 110) groups (p = .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology - Self-Report (IDS-SR(30)), were 17.0% (active) and 7.3% (sham) (p = .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. CONCLUSIONS: This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression.

Adult↗

Clinical diagnosis and management of Alzheimer's disease.

The diagnosis of dementia of the Alzheimer's type is defined by criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition and the National Institute of Neurologic, Communicative Disorders and Stroke-AD and Related Disorders Association. The latter divides diagnosis into definite, probable, and possible Alzheimer's disease (AD), with definitive diagnosis requiring pathologic confirmation. Both criteria require that other causes of dementia are excluded. A diagnosis of AD can be made with reasonably high accuracy using a combination of clinical criteria, neuropsychologic testing, and conventional CT and MR imaging. There is increasing emphasis on early recognition. Although current therapies produce a mild improvement in symptoms, there are several disease-modifying therapies on the horizon. This article reviews current standards in clinical diagnosis and management.

Aged↗

Age-related characteristics of depression: a preliminary STAR*D report.

OBJECTIVE: Studies have shown that age is a determinant in the course of major depressive disorder. Age has been associated with depression severity; it has also been associated with varying depressive symptomatology. The authors explore the relationships between current age and depression severity, course of illness, presenting symptom features, and comorbid symptoms. METHODS: Baseline clinical and sociodemographic information was collected on 1,498 participants enrolled in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study. Five age cohorts (18-25, 26-35, 36-50, 51-65, and 66-75) were compared on both sociodemographic and clinical factors. Depressive symptoms were measured with the 30-item clinician-rated Inventory of Depressive Symptomatology. RESULTS: Clinically meaningful differences were found among age cohorts on several clinical and depressive symptom features. Older patients (51-65 and 66-75) endorsed longer durations of illness, more major depressive episodes, a later age at onset of their first major depressive episode, and more general medical comorbidities. Older patients had more middle and terminal insomnia, less irritability, and less hypersomnia. They were less likely to hold negative views of themselves or of their future and were less likely to report previous suicide attempts. Older patients were less likely to endorse symptoms consistent with generalized anxiety disorder, social phobia, panic disorder, and drug abuse. CONCLUSIONS: These cross-sectional data indicate that different age-cohorts present with varying sociodemographic and clinical characteristics, as well as general-medical and psychiatric comorbid conditions.

Adolescent↗

Two-year outcome of vagus nerve stimulation (VNS) for treatment of major depressive episodes.

BACKGROUND: Vagus nerve stimulation (VNS) had antidepressant effects in an initial open, acute phase pilot study of 59 participants in a treatment-resistant major depressive episode (MDE). We examined the effects of adjunctive VNS over 24 months in this cohort. METHOD: Adult outpatients (N = 59) with chronic or recurrent major depressive disorder or bipolar (I or II) disorder and experiencing a treatment-resistant, nonpsychotic MDE (DSM-IV criteria) received 2 years of VNS. Changes in psychotropic medications and VNS stimulus parameters were allowed only after the first 3 months. Response was defined as > or = 50% reduction from the baseline 28-item Hamilton Rating Scale for Depression (HAM-D-28) total score, and remission was defined as a HAM-D-28 score < or = 10. RESULTS: Based on last observation carried forward analyses, HAM-D-28 response rates were 31% (18/59) after 3 months, 44% (26/59) after 1 year, and 42% (25/59) after 2 years of adjunctive VNS. Remission rates were 15% (9/59) at 3 months, 27% (16/59) at 1 year, and 22% (13/59) at 2 years. By 2 years, 2 deaths (unrelated to VNS) had occurred, 4 participants had withdrawn from the study, and 81% (48/59) were still receiving VNS. Longer-term VNS was generally well tolerated. CONCLUSION: These results suggest that patients with chronic or recurrent, treatment-resistant depression may show long-term benefit when treated with VNS.

Ambulatory Care↗

Relationship between somatization and remission with ECT.

Patients treated with electroconvulsive therapy (ECT) were divided into those with less severe depression and those with more severe depression. In the less severely depressed group, high somatic anxiety and hypochondriasis predicted a low likelihood of sustained remission with ECT. In the more severely depressed group, these traits were not predictive of ECT outcome.

Adult↗

Speed of response and remission in major depressive disorder with acute electroconvulsive therapy (ECT): a Consortium for Research in ECT (CORE) report.

BACKGROUND: Remission of illness in patients with major depressive disorder (MDD) is achieved in less than half of patients initially treated with medication. Electroconvulsive therapy (ECT) is another treatment option. We report the speed of response and remission rates in a cohort of depressed patients who received a course of acute-phase ECT in the initial phase of an ongoing multicenter randomized trial of continuation ECT versus pharmacotherapy. METHOD: Patients with MDD according to DSM-IV criteria received bilateral ECT 3 times weekly. Prior to each treatment, a 24-item Hamilton Rating Scale for Depression (HAM-D-24) score was obtained by a clinical rater. Sustained response was defined as a > or = 50% reduction in baseline HAM-D-24 score for at least 2 and all subsequent measurement occasions. Remission was defined as HAM-D-24 scores of < or = 10 for at least the last 2 consecutive assessments. Data were collected from May 1997 through November 2000. RESULTS: Of the 253 patients who entered the study, 86% (N = 217) completed the acute course of ECT. Sustained response occurred in 79% of the sample, and remission occurred in 75% of the sample (N = 253); 34% (85/253) of patients achieved remission at or before ECT #6 (week 2), and 65% (164/253) achieved remission at or before ECT #10 (weeks 3-4). Over half (54%; 136/253) had an initial first response by ECT #3 (end of week 1). CONCLUSION: ECT was associated with rapid response and remission in a high percentage of patients. ECT warrants early consideration in treatment algorithms for patients with MDD.

Adult↗

Vagus nerve stimulation (VNS) for major depressive episodes: one year outcomes.

BACKGROUND: Vagus nerve stimulation has shown promising results in an open, acute phase pilot study of adults in a treatment-resistant major depressive episode. This open, naturalistic follow-up study was conducted to determine whether the initial promising effects were sustained, and whether changes in function would be observed. METHODS: Thirty adult outpatients in a treatment-resistant, nonpsychotic major depressive episode received an additional 9 months of vagus nerve stimulation treatment following exit from the 3-month acute study. Changes in psychotropic medications and vagus nerve stimulation stimulus parameters were allowed during this longer-term follow-up study. A priori definitions were used to define response (> or = 50% reduction in baseline Hamilton Rating Scale for Depression total score) and remission (Hamilton Rating Scale for Depression < or = 10). RESULTS: The response rate was sustained [40% (12/30) to 46% (13/28); p =.317] and the remission rate significantly increased [17% (5/30) to 29% (8/28); p =.045] with an additional 9 months of long-term vagus nerve stimulation treatment after exit from the acute study (1 year total vagus nerve stimulation treatment). Significant improvements in function between acute study exit and the 1-year follow-up assessment as measured by the Medical Outcomes Study Short Form-36 were observed. CONCLUSIONS: Longer-term vagus nerve stimulation treatment was associated with sustained symptomatic benefit and sustained or enhanced functional status in this naturalistic follow-up study.

Adult↗

Substance use disorder comorbidity in major depressive disorder: an exploratory analysis of the Sequenced Treatment Alternatives to Relieve Depression cohort.

Patients with major depressive disorder (MDD) often present with concurrent substance use disorders (SUD) involving alcohol and/or illicit drugs. This analysis compares the depressive symptomatic presentation and a range of clinical and demographic features of patients with MDD and concurrent SUD symptoms vs those without SUD symptoms, to clarify how these two differ and to determine whether concurrent SUD symptoms may alter the clinical presentation of MDD. The first 1500 outpatients with nonpsychotic MDD enrolled in the Sequenced Treatment Alternatives to Relieve Depression study were divided into those with and without concurrent SUD symptoms as ascertained by a self-report instrument, the Psychiatric Diagnostic Screening Questionnaire (PDSQ). Of the 1484 cases with completed baseline PDSQ, 28% (n = 419) of patients with MDD were found to endorse symptoms consistent with current SUD. Patients with symptoms consistent with SUD were more likely to be men (P < .0001), to be either divorced or never married (P = .018), to have a younger age of onset of depression (P = .014), and to have a higher rate of previous suicide attempts (P = .014) than those without SUD symptoms. Patients with major depressive disorder who have symptoms consistent with SUD endorsed greater functional impairment attributable to their illness than those without concurrent SUD symptoms (P = .0111). The presence of SUD symptoms did not alter the overall depressive symptom pattern of presentation, except that the dual-diagnosed patients had higher levels of hypersomnia (P = .006), anxious mood (P = .047), and suicidal ideation (P = .036) compared to those without SUD symptoms. In conclusion, gender, marital status, age of onset of major depression, functional impairment, and suicide risk factors differ in depressed patients with concurrent SUD symptoms compared to those without SUD comorbidity.

Adult↗