SOLICITATION NOTICE
B -- An Investigation of the Efficacy in Childhood Obsessive-Compulsive Disorder of Riluzole: An Antiglutamatergic Agent
- Notice Date
- 4/30/2009
- Notice Type
- Presolicitation
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- RFQ1043383
- Archive Date
- 5/29/2009
- Point of Contact
- Liem T Nguyen,, Phone: 3014358780
- E-Mail Address
-
ln18x@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Drug Abuse (NIDA), Support Station/Simplified Acquisitions (SS/SA) Branch on behalf of the National Institute on Mental Health (NIMH) seeks to procure on a sole source basis developing and validating services from Frontage Laboratories. This acquisition will be processed under FAR Part 12-Acquisition for Commercial Items and will be made pursuant to the authority of FAR 13.5 to use Simplified Acquisition Procedure for commercial items. Obsessive-Compulsive Disorder (OCD) is a chronic psychiatric disorder characterized by the presence of intrusive and unwanted obsessional thoughts and images and of compulsive behaviors. Its presentation during childhood is similar to that seen in adulthood, except that children sometimes lack insight into the senselessness of the thoughts and behaviors. In a recent report on a multi-site study of childhood OCD, Cognitive behavioral therapy (CBT) alone at one site fared little better than placebo (March et al, 2004). There is a pressing need, then, for the development of alternative, novel treatments for pediatric OCD. Neuropsychological and neuroimaging data suggest that OCD may arise from dysfunction of orbitofronto-striato-thalamocortical circuitry. Glutamate plays a crucial role in the regulation of excitatory activity within this circuit and maybe involved in the etiopathogenesis of OCD. If so, then agents which reduce glutamatergic neurotransmission may provide unique antiobsessional benefits. Riluzole is a medication that reduces glutamatergic activity. It is currently being studied in adults with OCD, and this two-stage study will evaluate the possibility that riluzole will help children with OCD. Riluzole has been approved by the Food and Drug Administration (FDA) for treatment of amyotrophic lateral sclerosis (ALS), and is currently under investigation at NIMH for treatment of depression. The first stage of this investigation has been completed. A double-blind, placebo-controlled trial is underway for children and adolescents who have OCD alone or OCD and an autism spectrum disorder (ASD). The trial is 12 weeks in duration, and Riluzole is used as a sole agent or as an augmentation to their currently inadequate therapy. Following the double-blind portion of the trial, subjects may receive three months of open-label treatment with Riluzole, if it is clinically indicated. All subjects will be followed at regular intervals until one year from baseline. Riluzole has been used for a single FDA indication (amyotrophic lateral sclerosis, an adult degenerative neurologic disorder) for over ten years. It is understood that whether active metabolites of the drug are present and at what level; what levels of drug and any metabolites are available at the sites of action in the brain; whether significant amounts of drug migrate to other compartments in the body; etc. Previously Frontage Laboratories agreed to develop and validate a methodology for measurement of riluzole levels (no metabolites at the time) in human plasma sent to the contractor from the NIMH stored subject samples, identified to the Laboratory only by number. Frontage Laboratories will also re-assay a proportion of samples in order to satisfy FDA regulations regarding quality controls. The contractor will provide written reports of quality assurance and reports of sample analysis data. The current plan is to analyze samples from the first half of the study, more than 100 samples from 44 patients. Based on the analysis of the data produced, the NIMH may analyze subsequent samples as they become available. The NIMH may also decide to try to measure drug metabolites in available and subsequent samples. This is not a solicitation for competitive quotations. However, if any interested party believes it can perform the requirement as detailed the vendor may submit a Statement of Capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NIDA/NIMH to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NIDA Office of Acquisitions, SS/SA Branch on or before 2:00 PM ET May 14, 2009. All questions must be in writing and can be emailed to Liem T Nguyen at ln18x@nih.gov or faxed to 301-480-1358. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award from the NIDA, vendor must be registered in the Online Representations and Certifications Applications (ORCA) at http://orca.bph.gov. In addition, vendor must be registered in the Central Contractor Registration (CCR) at www.ccr.gov. No collect call will be accepted. Please reference the RFQ# 1043383 on all correspondence.
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