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NCT ID: NCT00146237 Completed - Depression Clinical Trials

Phenytoin as an Augmentation for SSRI Failures

Start date: November 2003
Phase: Phase 4
Study type: Interventional

About two-thirds of depressed patients respond to a standard course of serotonin specific reuptake inhibitor (SSRI's) within 3-4 weeks. While some clinicians advise continued watchful waiting after this time or switch to a different reuptake-blocker based antidepressant, result of such conservative strategies are usually disappointing. For severe depression electroconvulsive therapy (ECT) is an option and for atypical depressions monoamine oxide inhibitors (MAO) inhibitors often give relief at this point. A unique strategy with both theoretical and practical implications is lithium augmentation (Fava et al, 1994). Addition of lithium to SSRI failures at 3-4 weeks is consistently and sometimes dramatically found to be helpful. This is considered true even by those authors who advocate use of lithium under usual circumstances only in bipolar patients. Lithium in recent years has been joined as a mood stabilizer by carbamazepine and valproate. Phenytoin, ignored for many years as a possible anticonvulsant mood stabilizer, has been recently reported in double-blind controlled trials to be anti-manic (Mishory et al, 2000) and also prophylactic in BP disorder (Mishory et al, 2003). Data on mood stabilizers other than lithium as augmentors in SSRI failures are sparse. Carbamazepine (Steinacher et al, 2002) and valproate (Barbee et al, 2002) have been used. Given our recent preliminary results of phenytoin's efficacy in unipolar depression (Nemets et al, 2005) and its analogy to lithium as a mood stabilizer, it seems important to study phenytoin as a possible augmentation of SSRI failures. We have published a negative study previously of inositol as an augmentation of SSRI failures, enrolling forty-two patients over two years (Nemets et al, 1999). Antidepressant failures are easier to recruit from referring physicians in our center than are untreated patients, whom clinicians are reluctant to refer for new drug studies given the adequacy of standard treatment in 2/3 of them. Thus we estimate that we could enroll 20 patients per year in such a study. Survey of the literature of Li augmentation suggests that 40 phenytoin vs. 40 placebo should give adequate power to detect a significant phenytoin effect if the phenytoin effect is similar to that of lithium.

NCT ID: NCT00145574 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol

Start date: November 2005
Phase: Phase 4
Study type: Interventional

This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin, simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.

NCT ID: NCT00145535 Completed - Glaucoma Clinical Trials

SOLX Titanium Sapphire Laser for Trabeculoplasty

Start date: May 2004
Phase: Phase 3
Study type: Interventional

Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.

NCT ID: NCT00143611 Completed - Sepsis Clinical Trials

Efficacy & Safety of Resatorvid in Adults With Severe Sepsis

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day all-cause mortality in subjects with severe sepsis.

NCT ID: NCT00143403 Completed - Clinical trials for Colorectal Neoplasms

Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

Start date: December 2001
Phase: Phase 3
Study type: Interventional

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

NCT ID: NCT00143234 Completed - Hypertension Clinical Trials

Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels

GEMINI-AALA
Start date: May 2004
Phase: Phase 3
Study type: Interventional

The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines

NCT ID: NCT00142298 Completed - Chronic Hepatitis B Clinical Trials

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

NCT ID: NCT00141947 Recruiting - Schizophrenia Clinical Trials

Bexarotene Treatment in Schizophrenia

Start date: September 2005
Phase: Phase 3
Study type: Interventional

In this proposed study, we aim to investigate the effects of Bexarotene (Targretin; LGD1069; 4-[1-{5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl} ethenyl] benzoic acid) on severity of psychopathology, cognitive impairment, and quality of life in schizophrenia patients in an open label trial. The rationale behind add-on oral bexarotene to ongoing antipsychotic treatment in schizophrenia patients is based on both the retinoid dysregulation hypothesis (Goodman, 1995) and the growth factors deficiency and synaptic destabilization hypothesis (Moises et al, 2002) of schizophrenia. In this clinical trial, a novel regimen of low dose bexarotene (Targretin, 75 mg/day) will be added for 6 weeks to the standard treatment of 15 schizophrenia patients on stable antipsychotic treatment. Participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research instruments will be used for assessment of efficacy and safety (psychopathology, and side effects). In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during therapy.

NCT ID: NCT00141193 Completed - Colorectal Adenoma Clinical Trials

Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

PRESAP
Start date: February 2001
Phase: Phase 3
Study type: Interventional

This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

NCT ID: NCT00140829 Recruiting - Spastic Paraplegias Clinical Trials

SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

Spatax
Start date: July 2003
Phase: Phase 1
Study type: Observational

Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very heterogeneous. More than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. These progressive disorders are often severe and fatal, due to the absence of specific therapy. The SPATAX network combines the experience of European clinicians and scientists working on these groups of diseases. Over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of DNA to participating laboratories, mapping of three new loci, and refinement of several loci). In addition to clinicians from Europe and Mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the SPATAX members, the group includes major European laboratories devoted to the elucidation of the molecular basis of these disorders. Each laboratory will centralize all families with a subtype of autosomal recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the responsible gene(s). Genome-wide scans are already underway in 61 families. Given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. The spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. The knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. The series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.