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Biomedical subjects

Michael J Gitlin

Publications and source records attributed to Michael J Gitlin.

11 recordsLinked to original sources

Classifying episodes in schizophrenia and bipolar disorder: criteria for relapse and remission applied to recent-onset samples.

Research on predicting and preventing episodes of schizophrenia and mood disorder lacks consistent, specific definitions of episodes. We present an operational system for identifying relapse, exacerbation, and remission of schizophrenia and bipolar disorder within longitudinal studies that involve repeated symptom assessments. Three major classes of episodic outcome are defined: relapse or significant exacerbation, nonrelapse, and stable, severe persisting symptoms. These major classes are further subdivided to distinguish nine categories of episodic outcome. To examine ease of use, interrater reliability, and validity, the classification system was applied to recent-onset samples of schizophrenia patients (N=77) and bipolar mood disorder patients (N=23) followed on medication for 9- to 12-month periods. A range of episodic outcomes were distinguished with high interrater reliability. Despite being prescribed continuous medication, 21% of the recent-onset schizophrenia patients and 61% of bipolar patients met criteria for relapse or significant exacerbation during this follow-up period. Predictive relationships support the validity of this system for classifying episodes. A computer program is available to facilitate its use. Use of these explicit definitions of episodes may help to clarify the relationship between episodic outcome and other fundamental domains of illness outcome, particularly other symptom dimensions, work functioning, and social functioning.

Adult↗

Placebo response in clinical trials of depression and its implications for research on chronic neuropathic pain.

This article reviews studies of the placebo response in antidepressant clinical trials, describes methods that have been attempted to decrease it, and discusses implications of the placebo response in depression for research on treatments for neuropathic pain. Literature reviews and research studies examining the placebo response in clinical trials of treatments for depression were reviewed. Existing data suggest that the placebo response in antidepressant clinical trials is substantial and that a high placebo response in a clinical trial is associated with a reduced likelihood of demonstrating the statistical superiority of antidepressant treatment vs. placebo. Attempts to decrease the placebo response in antidepressant clinical trials have generally not been effective. In addition, there is little evidence that decreasing the placebo response rate makes it more likely that superiority of active vs. placebo treatment will be demonstrated. Analyses of neuropathic pain clinical trial databases should be conducted to examine factors associated with trial outcomes. Aspects of neuropathic pain clinical trials that require further consideration or investigation include the following: (a) exclusion of patients with mild pain severity; (b) exclusion of patients with short episode duration; (c) maximizing reliability, validity, and responsiveness of outcome measures; (d) minimizing extraneous contact with investigative staff and other sources of nonspecific therapeutic effects; (e) trial duration; (f) minimizing the number of treatment groups; (g) flexible vs. fixed dose designs; (h) strategies for identifying patients and accelerating enrollment; (i) identification of run-in periods that reduce the placebo response rate; and (j) registration of clinical trials and publication of negative studies.

Antidepressive Agents↗

Patterns of alcohol consumption in bipolar patients comorbid for alcohol abuse or dependence.

OBJECTIVES: Despite a high prevalence rate, patients with bipolar disorder and active alcohol use are routinely excluded from controlled clinical trials leaving clinicians with little evidence-based medicine to guide treatment. This report evaluates preliminary data of alcohol consumption patterns utilizing the Alcohol Timeline Followback (TLFB) method in actively drinking patients with bipolar disorder. METHODS: A sample of 30 patients underwent a Structured Diagnostic Interview for DSM-IV (SCID-IV) as well as completing various measures of alcohol use and associated morbidity. RESULTS: In the month prior to study entry, the TLFB reported 18.4/30+/-9.12 drinking days, 9.9+/-4.73 drinks per drinking day and 169.4+/-101.71 total standard drinks for this study group. There was a significant difference in the number of drinks per drinking day between those diagnosed with rapid cycling than non-rapid cycling bipolar disorder and those with a new diagnosis versus established diagnosis of bipolar disorder. DISCUSSION: This study highlights heavy alcohol use in patients with bipolar disorder and alcohol comorbidity. The TLFB method provides 'real world' quantification of use. Further studies are encouraged to elucidate implications of heavy drinking patterns as found in our rapid cycling and newly diagnosed cohorts.

Adult↗

Electrodermal predictors of functional outcome and negative symptoms in schizophrenia.

The ability of electrodermal variables to predict negative symptoms and functional outcome over a 1-year period in schizophrenia was investigated in 78 young, recent-onset outpatients. Patients were stabilized on standardized medication and largely free of psychotic symptoms. Higher levels of both tonic (skin conductance level, nonspecific skin conductance response rate) and phasic (number of skin conductance orienting responses) activity were associated with more negative symptoms and with a combination of poorer social and occupational outcome at 1-year follow-up. This pattern was seen in both male and female patients, and in older and younger patients. Results are interpreted as suggesting that high levels of arousal and overreactivity to the environment may interfere with efficient cognitive processing in schizophrenia, contributing to poor outcome, and that negative symptoms might partially serve as a means of coping with overarousal.

Adult↗

Self-efficacy and neurocognition may be related to coping responses in recent-onset schizophrenia.

Although stressful life events can trigger psychotic and depressive symptom exacerbation in schizophrenia, many patients who experience stressful events do not subsequently relapse. Models of vulnerability, stress, and protective factors in schizophrenia suggest that effective coping responses may serve as protective factors. Coping behavior, in turn, may be influenced by a schizophrenia patient's level of self-efficacy and neurocognitive functioning. Using the Coping Responses Inventory, we examined how 29 recent-onset schizophrenia outpatients and 24 demographically matched normal comparison subjects responded to a negative interpersonal life event. Approach oriented coping responses, such as "Think of different ways to deal with the problem" and "Make a plan of action and follow it," were used significantly more often by normal subjects (M=2.27) than by schizophrenia patients (M=1.89; p < 0.02). Among schizophrenia patients, greater use of approach, problem-focused coping strategies was associated with high self-efficacy (r=0.55, p < 0.01) and better performance on a measure of sustained attention emphasizing perceptual processing (r=0.42, p < 0.05). Multiple regression indicated that self-efficacy and sustained attention accounted for 56% of the variance in the use of problem-focused coping, strategies by schizophrenia patients.

Adaptation, Psychological↗

Unmet needs in bipolar depression.

Bipolar disorders, particularly bipolar spectrum disorders, frequently go unrecognized and undiagnosed by clinicians and thus remain untreated or inappropriately treated. Although the symptoms of bipolar I disorder are widely acknowledged and recognized among clinicians, epidemiology sampling studies over the past several years have found that bipolar II disorder and bipolar spectrum disorders are likely to be more prevalent and more challenging to diagnose, particularly as depressive presentations are far more common in these groups. Bipolar disorder is associated with increased morbidity and mortality, as well as higher healthcare costs, but it is unclear how much of the consequences of bipolar disorder are unrecognized in the face of poor recognition of bipolar II and bipolar spectrum disorders. This article addresses challenges in diagnosing and treating bipolar disorder in the face of a depressive episode, and offers guidelines for recognizing and appropriately managing these patients. Studies with the newer anticonvulsant mood stabilizer lamotrigine have shown antidepressant effects in bipolar disorder, and may fill an unmet need for treatment options in patients who present with depression in the context of bipolar disorder.

Antidepressive Agents↗

Acceleration and augmentation strategies for treating bipolar depression.

Despite the prevalence and morbidity of bipolar depression, few randomized treatment trials have been conducted to assess clinical efficacy. Even fewer studies have assessed approaches that optimize treatment response for bipolar depression. This review will define three types of common combination strategies--adjunctive, acceleration and augmentation--and discuss the limited literature of controlled studies reported on acceleration and augmentation approaches.

Adrenergic beta-Antagonists↗

Intra- and interindividual variations in steady-state plasma concentrations of risperidone and 9-hydroxyrisperidone in schizophrenic patients treated chronically with various doses of risperidone.

The intra- and interindividual variability in apparent steady-state plasma levels of risperidone (RSP) and its metabolite 9-hydroxyrisperidone (9-OHRSP) in schizophrenic patients was investigated. Patients (n = 46, age 26.4 +/- 5.3 years) with diagnosed schizophrenia were treated with a fixed daily oral dose of RSP (1-12 mg/d). The steady-state plasma samples from these patients were collected over a period of 5 years and a total of 549 visits. Plasma concentrations of RSP and 9-OHRSP were determined using a highly sensitive and specific LC-MS-MS method with a detection limit of 0.1 ng/mL. All plasma samples had measurable amounts of 9-OHRSP; however, RSP was nondetectable (<0.1 ng/mL) in 18% of the plasma samples. 9-OHRSP levels were, on average, approximately 22 times higher than those of RSP. The plasma levels of RSP and 9-OHRSP varied widely among patients receiving similar doses of RSP, and the intra- and interindividual variations of RSP and 9-OHRSP plasma levels were found to be large. The data indicated that there was no significant change in the steady-state levels of either RSP or 9-OHRSP during the treatment period. Similarly, the dose-normalized concentration did not vary significantly during the treatment period or with the administered dose. The absence of RSP in many plasma samples (<0.1 ng/mL) and presence of 9-OHRSP at severalfold higher concentrations than RSP indicate that measuring plasma levels of RSP alone may lead to erroneous interpretation in plasma level monitoring studies. The current data support the fact that it is important to measure steady-state levels of total active moiety by analyzing both RSP and 9-OHRSP for plasma drug monitoring.

Adult↗

Subsyndromal depression is associated with functional impairment in patients with bipolar disorder.

BACKGROUND: The purpose of this study was to assess whether a relationship exists between mild depressive symptoms and overall functioning in subjects with bipolar disorder. METHOD: Twenty-five male subjects with bipolar I disorder (DSM-III-R criteria), who had not experienced a DSM-III-R episode of mania, hypomania, or major depression for 3 months as determined using the Structured Clinical Interview for DSM-III-R, were evaluated for degree of depressive symptoms using the Hamilton Rating Scale for Depression (HAM-D) and for overall functional status using the Global Assessment of Functioning (GAF, DSM-IV Axis V). RESULTS: GAF scores were significantly negatively correlated with HAM-D scores (r = -0.61, df = 23, p = .001), despite the fact that no patient had a HAM-D score high enough to be considered clinically depressed. CONCLUSION: The results of this study support a relationship between subsyndromal depressive symptoms and functional impairment in bipolar subjects, despite their not meeting threshold criteria for a major depressive episode. These findings raise the possibility that in some patients with bipolar disorder subsyndromal depressive symptoms might contribute to ongoing functional impairment.

Adaptation, Psychological↗

Bupropion-sustained release as a treatment for SSRI-induced sexual side effects.

Twenty-four subjects treated with serotonin reuptake inhibitors for a depressive disorder who had new-onset sexual side effects coincident with antidepressant treatment were treated with escalating doses of bupropion SR up to 300 mg daily for 7 weeks. Global response rates were 46% for women and 75% for men. All sexual side effects improved in response to bupropion SR in both men and women with no differential effect on any one sexual side effect. Most of the improvement (more than 50%) occurred within the first 2 weeks and at low dose (100-200 mg/day). When prescribed in an open fashion, bupropion SR appeared to be effective in treating all the major categories of sexual side effects.

Adolescent↗