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Efficacy of the Melatonin Agonist in the Treatment of Depression

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85868
Program Year/Program:
2007 / SBIR
Agency Tracking Number:
MH079518
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
P2D, INC.
10101 Alliance Rd CINCINNATI, OH 45242-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Efficacy of the Melatonin Agonist in the Treatment of Depression
Agency: HHS
Contract: 1R43MH079518-01
Award Amount: $233,954.00
 

Abstract:

DESCRIPTION (provided by applicant): P2D Inc. is developing a synthetic melatonin agonist, PD6735, for the treatment of depression. Preliminary Studies indicate that PD6735 produces an antidepressant-like effect in rodents. Additional preclinical studies i ndicate that PD6735 is safe and is a high-affinity agonist at MT1 and MT2 receptors. The goal of this Phase 1 SBIR proposal is to determine PD6735 efficacy in two widely employed rodent models of depression. Preliminary Studies indicate that the PD6735 and the antidepressant imipramine produce similar antidepressant-like effects in a preclinical model of depression, open filed. We propose to extend our Preliminary Studies and determine PD6735 efficacy in two widely employed models of depression: 1) the forc ed swim test (Porsolt test), and 2) the chronic mild stress model of depression. In both models we will also employ the tricyclic antidepressant imipramine and the selective serotonin uptake inhibitor (SSRI) fluoxetine as positive comparators. Additionally , the antidepressant effect of melatonin will be determined. Our Specific Aims are: Specific Aim 1: Determine the antidepressant activity of acute and chronic administration of the melatonin agonist PD6735 in the forced swim test preclinical model of depre ssion (Porsolt test) in rats. Specific Aim 2: Determine the antidepressant activity of acute and chronic administration of the melatonin agonist PD6735 in the chronic mild stress model of depression in rats. PHS 398/2590 (Rev. 09/04) Page Continuation Form at Page This application proposed to determine if our proprietary melatonin agonist, PD6735, demonstrates antidepressant efficacy in preclinical models of depression. About 10% of all men in America and up to 25% of all women will experience depression in their lifetime according to the National Institute of Mental Health. In the United States, depression is responsible for up to 70% of all psychiatric hospitalizations and about 40% of suicides. The cost of depression in the United States was estimated by N IMH to be 83 billion including both 26 billion in costs of treatment and 57 billion in losses such as absenteeism, reduced productivity at work and the value of lifetime earnings due to suicide-related deaths.

Principal Investigator:

Frank Zemlan
5134756618
FZEMLAN@P2DINC.COM

Business Contact:

Frank P. Xemlan
rmooconnor@p2dinc.com
Small Business Information at Submission:

P2D, INC.
P2D, INC. 3130 HIGHLAND AVE, 3RD FL CINCINNATI, OH 45219

EIN/Tax ID: 202224724
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No