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Articles by A. C Leon
Total Records ( 5 ) for A. C Leon
  J. T Sherrill , D. I Sommers , A. A Nierenberg , A. C Leon , S Arndt , K Bandeen Roche , J Greenhouse , D Guthrie , S. L Normand , K. A Phillips , M. K Shear and R. Woolson

OBJECTIVE: The authors summarize points for consideration generated in a National Institute of Mental Health (NIMH) workshop convened to provide an opportunity for reviewers from different disciplines—specifically clinical researchers and statisticians—to discuss how their differing and complementary expertise can be well integrated in the review of intervention-related grant applications. METHODS: A 1-day workshop was convened in October, 2004. The workshop featured panel presentations on key topics followed by interactive discussion. This article summarizes the workshop and subsequent discussions, which centered on topics including weighting the statistics/data analysis elements of an application in the assessment of the application’s overall merit; the level of statistical sophistication appropriate to different stages of research and for different funding mechanisms; some key considerations in the design and analysis portions of applications; appropriate statistical methods for addressing essential questions posed by an application; and the role of the statistician in the application’s development, study conduct, and interpretation and dissemination of results. RESULTS: A number of key elements crucial to the construction and review of grant applications were identified. It was acknowledged that intervention-related studies unavoidably involve trade-offs. Reviewers are helped when applications acknowledge such trade-offs and provide good rationale for their choices. Clear linkage among the design, aims, hypotheses, and data analysis plan and avoidance of disconnections among these elements also strengthens applications. CONCLUSION: The authors identify multiple points to consider when constructing intervention-related grant applications. The points are presented here as questions and do not reflect institute policy or comprise a list of best practices, but rather represent points for consideration.

  B. S Meyers , A. J Flint , A. J Rothschild , B. H Mulsant , E. M Whyte , C Peasley Miklus , E Papademetriou , A. C Leon , M Heo and for the STOP PD Group

Context  Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features.

Objectives  To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age.

Design  Twelve-week, double-blind, randomized, controlled trial.

Setting  Clinical services of 4 academic sites.

Patients  Two hundred fifty-nine subjects with MD with psychotic features randomized by age (<60 or ≥60 years) (mean [standard deviation (SD)], 41.3 [10.8] years in 117 younger adults vs 71.7 [7.8] years in 142 geriatric participants).

Intervention  Target doses of 15 to 20 mg of olanzapine per day plus masked sertraline or placebo at 150 to 200 mg per day.

Main Outcome Measure  Remission rates of MD with psychotic features.

Results  Treatment with olanzapine/sertraline was associated with higher remission rates during the trial than olanzapine/placebo (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.12-1.47; P < .001); 41.9% of subjects who underwent combination therapy were in remission at their last assessment compared with 23.9% of subjects treated with monotherapy (21 = 9.53, P = .002). Combination therapy was comparably superior in both younger (OR, 1.25; 95% CI, 1.05-1.50; P = .02) and older (OR, 1.34; 95% CI, 1.09-1.66; P = .01) adults. Overall, tolerability was comparable across age groups. Both age groups had significant increases in cholesterol and triglyceride concentrations, but statistically significant increases in glucose occurred only in younger adults. Younger adults gained significantly more weight than older subjects (mean [SD], 6.5 [6.6] kg vs 3.3 [4.9] kg, P = .001).

Conclusions  Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks.

Trial Registration Identifier: NCT00056472

  J. H Kocsis , A. J Gelenberg , B. O Rothbaum , D. N Klein , M. H Trivedi , R Manber , M. B Keller , A. C Leon , S. R Wisniewski , B. A Arnow , J. C Markowitz , M. E Thase and for the REVAMP Investigators

Context  Previous studies have found that few chronically depressed patients remit with antidepressant medications alone.

Objective  To determine the role of adjunctive psychotherapy in the treatment of chronically depressed patients with less than complete response to an initial medication trial.

Design  This trial compared 12 weeks of (1) continued pharmacotherapy and augmentation with cognitive behavioral analysis system of psychotherapy (CBASP), (2) continued pharmacotherapy and augmentation with brief supportive psychotherapy (BSP), and (3) continued optimized pharmacotherapy (MEDS) alone. We hypothesized that adding CBASP would produce higher rates of response and remission than adding BSP or continuing MEDS alone.

Setting  Eight academic sites.

Participants  Chronically depressed patients with a current DSM-IV–defined major depressive episode and persistent depressive symptoms for more than 2 years.

Interventions  Phase 1 consisted of open-label, algorithm-guided treatment for 12 weeks based on a history of antidepressant response. Patients not achieving remission received next-step pharmacotherapy options with or without adjunctive psychotherapy (phase 2). Individuals undergoing psychotherapy were randomized to receive either CBASP or BSP stratified by phase 1 response, ie, as nonresponders (NRs) or partial responders (PRs).

Main Outcome Measures  Proportions of remitters, PRs, and NRs and change on Hamilton Scale for Depression (HAM-D) scores.

Results  In all, 808 participants entered phase 1, of which 491 were classified as NRs or PRs and entered phase 2 (200 received CBASP and MEDS, 195 received BSP and MEDS, and 96 received MEDS only). Mean HAM-D scores dropped from 25.9 to 17.7 in NRs and from 15.2 to 9.9 in PRs. No statistically significant differences emerged among the 3 treatment groups in the proportions of phase 2 remission (15.0%), partial response (22.5%), and nonresponse (62.5%) or in changes on HAM-D scores.

Conclusions  Although 37.5% of the participants experienced partial response or remitted in phase 2, neither form of adjunctive psychotherapy significantly improved outcomes over that of a flexible, individualized pharmacotherapy regimen alone. A longitudinal assessment of later-emerging benefits is ongoing.

Trial Registration Identifier: NCT00057551

  D. A Solomon , A. C Leon , W. H Coryell , J Endicott , C Li , J. G Fiedorowicz , L Boyken and M. B. Keller

Context  The phenomenology of bipolar I disorder affects treatment and prognosis.

Objective  To describe the duration of bipolar I mood episodes and factors associated with recovery from these episodes.

Design  Subjects with Research Diagnostic Criteria bipolar I disorder were prospectively followed up for as long as 25 years. The probability of recovery over time from multiple successive mood episodes was examined with survival analytic techniques, including a mixed-effects grouped-time survival model.

Setting  Five US academic medical centers.

Participants  Two hundred nineteen subjects with bipolar I disorder.

Main Outcome Measures  Level of psychopathology was assessed with the Longitudinal Interval Follow-up Evaluation every 6 months for the first 5 years of follow-up and annually thereafter.

Results  The median duration of bipolar I mood episodes was 13 weeks. More than 75% of the subjects recovered from their mood episodes within 1 year of onset. The probability of recovery was significantly less for an episode with severe onset (psychosis or severe psychosocial impairment in week 1 of the episode) (hazard ratio [HR] = 0.746; 95% confidence interval [CI], 0.578-0.963; P = .02) and for subjects with greater cumulative morbidity (total number of years spent ill with any mood episode) (HR = 0.917; 95% CI, 0.886-0.948; P < .001). Compared with the probability of recovery from a major depressive episode, there was a significantly greater probability of recovery from an episode of mania (HR = 1.713; 95% CI, 1.373-2.137; P < .001), hypomania (HR = 4.502; 95% CI, 3.466-5.849; P < .001), or minor depression (HR = 2.027; 95% CI, 1.622-2.534; P < .001) and, conversely, a significantly reduced probability of recovery from a cycling episode (switching from one pole to the other without an intervening period of recovery) (HR = 0.438; 95% CI, 0.351-0.548; P < .001).

Conclusions  The median duration of bipolar I mood episodes was 13 weeks, and the probability of recovery was significantly decreased for cycling episodes, mood episodes with severe onset, and subjects with greater cumulative morbidity.

  D. A Solomon , A. C Leon , J Endicott , W. H Coryell , C Li , J. G Fiedorowicz and M. B. Keller


Much remains unknown about the phenomenology of bipolar I disorder.


To determine the type of bipolar I mood episodes that occur over time, and their relative frequency.


A total of 219 individuals with Research Diagnostic Criteria bipolar I disorder were prospectively followed for up to 25 years (median 20 years). Psychopathology was assessed with the Longitudinal Interval Follow-up Evaluation.


Overall, 1208 mood episodes were prospectively observed. The episodes were empirically classified as follows: major depression, 30.9% (n = 373); minor depression, 13.0% (n = 157); mania, 20.4% (n = 246); hypomania, 10.4% (n = 126); cycling, 17.3% (n = 210); cycling plus mixed state, 7.8% (n = 94); and mixed, 0.2% (n = 2).


Cycling episodes constituted 25% of all episodes. Work groups revising ICD–10 and DSM–IV should add a category for bipolar I cycling episode.

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