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NCT02118610 · ClinicalTrials.gov registry record · NA
Treatment of Schizophrenia With L-tetrahydropalmatine (l-THP): a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT02118610 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 63 participants.
The verdict
NCT02118610, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study 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 (e.g., 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
Interventions
- DRUG Sugar pill
- DRUG L-tetrahydropalmatine (30mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2014-09 |
| Est. Completion | 2019-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02118610
The ClinicalTrials.gov registry entry for NCT02118610 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sugar pill is the first listed.
NCT02118610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02118610 about?
NCT02118610 is a clinical study titled "Treatment of Schizophrenia With L-tetrahydropalmatine (l-THP): a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity". 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 ...
What is the current status of trial NCT02118610?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2014-09. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02118610?
The interventions under investigation include: Sugar pill (DRUG), L-tetrahydropalmatine (30mg) (DRUG).
Who is sponsoring clinical trial NCT02118610?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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