Ignite Creation Date:
2024-05-06 @ 2:43 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02118610
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2014-04-14
Brief Title:
Treatment of Schizophrenia With L-tetrahydropalmatine l-THP a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Treatment of Schizophrenia With L-tetrahydropalmatine l-THP a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Schizophrenia is a devastating and complex illness with multiple symptom and behavioral manifestations Antipsychotic medications are the mainstay of treatment however many patients only partially respond to treatment Development of new treatment has not progressed rapidly in part because the underlying etiopathophysiology of the illness is not well understood To date all pharmacological treatments approved for use in schizophrenia involve primary modulation of the dopamine system Many agents without dopamine action have failed to demonstrate efficacy There is growing evidence that schizophrenia may be in part due to an inflammatory process and pharmacological treatment approaches that decrease inflammation have shown promise Thus treatments that may have anti-inflammatory properties eg TNF-alpha inhibition but also possess dopamine modulation may prove to be beneficial This novel medication l-tetrahydropalmatine l-THP has robust anti-inflammatory properties particularly TNF-alpha and ICAM inhibition has antiprotozoal activity and possesses an antipsychotic-like pharmacological profile of D1 D2 and D3 receptor antagonism The high affinity of l-THP for D1 versus D2 receptors distinguishes it from first generation antipsychotics and its D1 to D2 ratio resembles that of the superior antipsychotic clozapine Also an almost identical compound l-stepholindine l-SPD demonstrates robust antipsychotic activity in humans both positive and negative symptoms and is currently used clinically in China l-THP has been used for over 40 years clinically in China has a good safety profile to date and represents a novel and exciting mechanism for schizophrenia treatment Initial safety data from our phase I study of l-THP 20 healthy controls shows excellent tolerability and lack of any substantial side effects L-THP has been tested in outpatient drug abuse trials for 4 weeks with good safety data Hu et al 2006 Yang et al 2003 Yang et al 2003 randomized this medication in over 120 participants for 4 weeks with 4 week observation without any notable side effects
We will test this compound 30 mg BID as an adjunct treatment in a randomized double-blind 4-week trial in which we will assess treatment efficacy changes in peripheral cytokine concentrations and secondarily antiprotozoal effects antibody titers to Toxoplasma gondii an infection that is known to occur at higher rates in schizophrenia than healthy controls and may be related in part to the illness
We will test this compound 30 mg BID as an adjunct treatment in a randomized double-blind 4-week trial in which we will assess treatment efficacy changes in peripheral cytokine concentrations and secondarily antiprotozoal effects antibody titers to Toxoplasma gondii an infection that is known to occur at higher rates in schizophrenia than healthy controls and may be related in part to the illness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None