1992 — 1997 |
Strober, Michael A |
R10Activity Code Description: Undocumented code - click on the grant title for more information. |
Lithium Prophylaxis in Adolescents With Bipolar Illness @ University of California Los Angeles
At present, no data exist on the value of long-term preventative lithium therapy in adolescents with bipolar affective illness. The main objective of this collaborative, multicenter proposal is to conduct a five-year double-blind placebo controlled study of lithium discontinuation in adolescents with bipolar illness. The participating institutions include UCLA (Michael Strober, PI), University of Pittsburgh (Neal Ryan, PI), and Brown University (Martin Keller, PI). Each site will recruit 10 patients per year who fulfill DSM-III-R criteria for bipolar affective illness. Subjects who will be eligible for enrollment into this discontinuation protocol are adolescents from Tanner stage III to 19 years, 11 months who have been stabilized on lithium for a period of at least 6 months and who have been asymptomatic on lithium without any other psychoactive medication for at least 3 months. Specific aims are: (1) to compare the efficacy of lithium vs placebo in preventing recurrences of either mania or depression, and in controlling subsyndromic symptoms and onset of nonaffective psychiatric disturbances; (2) to identify predictors of differential outcome within and across treatment cells; and (3) to assess emergent side effects and overall compliance with lithium maintenance during the study period. We believe that this study--the first of its kind, to our knowledge--will add significant new clinical and theoretical knowledge to the emerging literature on pediatric psychopharmacology. Interlocking, identical protocols are being submitted simultaneously by Martin Keller, M.D., Brown University, Neal Ryan, M.D., University of Pittsburgh, and Michael Strober, Ph.D., University of California at Los Angeles.
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0.958 |
2000 — 2005 |
Strober, Michael A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Course and Outcome For Adolescents With Bipolar Illness @ University of California Los Angeles
outcomes research; bipolar depression; disease /therapy duration; mental health epidemiology; relapse /recurrence; social psychology; clinical research; adolescence (12-20); human subject;
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0.958 |
2000 — 2001 |
Strober, Michael A |
U01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Treatment of Ssri Resistant Depression in Adolescents @ University of California Los Angeles
A 5-year, 6-site study, consisting of 6 interlocking RO1 applications, is proposed to study the treatment of SSR-resistant depression in 400 adolescent subjects. Subjects will be those with DSM-IV MDD, currently in treatment, and still depressed despite at least 4 weeks of treatment at an adequate dosage (20mg) and at least 2 weeks of treatment at a higher dosage (40mg) of either paroxetine or fluoxetine. We focus on these two SSRIs because they are most commonly used drugs in this class, and are the only two for which efficacy has been demonstrated in the treatment of adolescent depression. After an initial assessment, the adolescents will be observed at the higher dosage of SSRI for an additional two weeks, and then reassessed. Those who show no significant response over that time (decrease in CDRS-R <20%) will be tapered from their current regimen and entered into the protocol. These 400 subjects will be assigned to one of four conditions to be delivered over 12 weeks. The rate of clinically acceptable response to treatment (defined as a CGI equal to or greater than 2 and equal to or less than 50% decrease in the CDRS-R) will be compared across the 4 cells in a 2x2 factorial design: (1) switch within SSRI class (those on paroxetine switch to fluoxetine; those on fluoxetine switch to paroxetine); (2) switch to a different class of agent (venlafaxine); (3) switch within SSRI class plus receive cognitive behavior therapy (CBT), and; (4) switch to a different class of agent (venlafaxine) plus CBT. Subjects who show a clinically acceptable response will receive 12 additional weeks of continuation treatment with the same intervention as in the acute phase. Non-responders will be offered 12 weeks of open treatment. All subjects will be followed up for 12 months after the continuation phase, regardless of treatment compliance. We hypothesize that there will be a medication effect (venlafaxine superior to SSRI switch), a CBT effect (CBT + medication superior to medication alone), and that CBT + venlafaxine will be superior to the other 3 cells. in addition, we hypothesize that the rate of relapse and recurrence will be lower in the CBT treated cells. The six sites participating, and the numbers of subjects to be enrolled at each are: Brown (40), Dallas (80), Galveston (80), Oregon (80), UCLA (n=40), the site of this application, and Pittsburgh (n=80), with the latter being the coordinating site for the overall study.
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0.958 |
2001 |
Strober, Michael A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Course and Outcome For Adolescents With Bipolar Ilness @ University of California Los Angeles
outcomes research; bipolar depression; disease /therapy duration; mental health epidemiology; relapse /recurrence; social psychology; clinical research; adolescence (12-20); human subject;
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0.958 |
2002 — 2005 |
Strober, Michael A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Genetics of Anorexia Nervosa @ University of California Los Angeles
DESCRIPTION (provided by applicant): Anorexia nervosa (AN) is a chronic and often fatal disorder that affects 0.3% of women. There is no FDA-approved treatment, and the mortality rate is 5% per decade. In addition to environmental influence, family and twin studies demonstrate substantial heritability for AN. Because the etiology of this devastating illness is not known, we undertook a pilot study to examine its genetic underpinnings. With the support of a private foundation, our multicenter collaboration has collected 196 multiplex AN kindreds from 7 sites across North America and Europe. With a limited sample, this pilot study has produced four suggestive linkages from a genome-wide scan, one very close to genome-wide significance (Chromosome 1 at 70 cM, p - 0.0001; Chr. 1 at 202 cM, LOD = 3 46. p = 0.00003; Chr. 2 at 102 cM, LOD = 2.22: p = 0.00070; and Chr. 13 at 102 cM. LOD = 2.50; p = 0.00035) The first suggestive linkage results from a subset of the sample, namely individuals with the restricting subtype of AN. The other results were obtained by incorporating two covariates, drive-for-thinness from the Eating Disorders lnventory-2 and the total score from the Yale-Brown Obsessive Compulsive Scale, into covariate-based linkage analysis. Based on these very promising linkage findings, we believe genes underlying liability to AN can be mapped by augmenting the pilot sample. Thus support is requested for a multicenter effort to collect 400 affected relative pairs with AN. Over a five year period, the 11 collaborating groups (10 clinical, 1 analytic) will collect diagnostic and other phenotypic data and blood samples from 400 multiplex AN kindreds. The UNIVERSITY OF PITTSBURGH is one of these research groups. each of which is submitting a nearly identical application as a group of collaborating ROls. Microsatellites will be genotyped at H 10 cM intervals across the genome using all new families. Linkage analyses will be conducted by using diagnostic and phenotypic data to confirm suggestive linkages from the pilot study and to identify new genomic regions of interest. The diagnostic and genetic data and lymphoblastoid cell lines (derived from blood samples) will become part of a national archival resource for genetic studies of AN through the NIMH Genetics Initiative.
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0.958 |
2006 — 2010 |
Strober, Michael A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Course and Outcome For Bipolar Disorder in Youth @ University of California Los Angeles
DESCRIPTION (provided by applicant): This competing continuation of the study "Course and Outcome of Bipolar Youth" (COBY) will extend the follow-up of the sample for 5 more years. COBY is collaboration by the University of Pittsburgh, Brown University, and UCLA to investigate the longitudinal course of pediatric bipolar disorder (BP). As of 10/1/2005, we achieved our recruitment goal of 430 youth (186 children and 244 adolescents) with BP spectrum disorders (I, II and Not Otherwise Specified--NOS) using state-of-the-art clinical and analytic methodologies. Preliminary analyses of COBY's data are showing that pediatric BP is a rapid fluctuating and chronic illness associated with high psychosocial morbidity. However, limited data exists on the phenomenology, treatment responsiveness, and how course is influenced by the developmental transitions from childhood to adolescence, and adulthood. The unprecedented scientific and public health implications of COBY will accrue from ongoing observational data on a large, clinically diverse cohort of rigorously diagnosed subjects, which will enable us to: (1) describe the naturalistic course of recovery and recurrence patterns, as well as rapid mood changes, subsyndromal symptoms, and well periods into early adulthood;(2) identify predictors of long-term course and outcome;(3) describe psychosocial outcomes from childhood to early young adulthood;(4) describe treatments received and their effects in mediating course patterns;and 5) to explore domains of cognitive functioning across development in children and adolescents with BP spectrum disorders. Beyond the acquisition of new knowledge about long-term temporal patterns of pediatric-onset BP, an intrinsic value of extending the study of our cohort for another 5 years is that we will determine whether, and how, clinical phenotypes, psychopathological course trajectories, cognitive development and other important outcome variables change as probands move across developmental stages from childhood to young adulthood. Continued follow-up of the COBY sample at 6-month intervals using adaptations of instruments from the successful adult Collaborative Depression Study (CDS), will make it possible to develop more comprehensive knowledge on the above-noted aims given its large size, ascertainment from multiple sites, demographic and clinical diversity, and inclusion of subjects across the broad range of disease severity.
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0.958 |