Psychotic Disorders Clinical Trial
Official title:
D-amino Acid Oxidase Inhibition for NMDA Modulation in Schizophrenia
Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.
The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission
has been regarded as a novel treatment approach. To date, several reported trials on
adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and
sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for
positive and negative symptoms.
DAAOI-1 is a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration
of D-amino acids. The aim of this project is to examine the efficacy and safety of add-on
treatment of DAAOI-1 in chronically stable schizophrenia patients who have been stabilized
with antipsychotics.
In the study, 60 schizophrenic patients are recruited into the 6-week trial and randomly
assigned into the two groups (1 gm/dDAAOI-1, or placebo) with a double-blind manner.
Positive and Negative Syndrome Scale (PANSS), Scales for the Assessment of Negative symptoms
(SANS), Global Assessment of Function (GAF), quality of life (QOL), Hamilton Depression
rating scale 17(HAM-D 17), Clinical Global Impression(CGI)and side effects are evaluated
every two weeks during the trial. Cognitive function ("7 domains of Measurement and
Treatment Research to Improve Cognition in Schizophrenia" [MATRICS])are assessed at weeks 0
and 6. The efficacies of two groups are compared.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
| Terminated |
NCT03230097 -
This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
|
Phase 2 | |
| Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
| Active, not recruiting |
NCT05726617 -
Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders
|
N/A | |
| Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
| Recruiting |
NCT02874573 -
Tocilizumab in Schizophrenia
|
Phase 1 | |
| Terminated |
NCT02584114 -
Brain Effects of Memory Training in Early Psychosis
|
N/A | |
| Completed |
NCT02906553 -
The Role of Nitric Oxide in Cognition in Schizophrenia
|
N/A | |
| Completed |
NCT01981356 -
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
|
Phase 0 | |
| Terminated |
NCT02841956 -
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Recruiting |
NCT02009969 -
Serial Comparisons of Abdominal and Neurological MRI Scans
|
N/A | |
| Recruiting |
NCT02848469 -
Irish Omega-3 Study
|
Phase 2 | |
| Completed |
NCT02648321 -
Motivational Intervention for Physical Activity in Psychosis
|
N/A | |
| Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
| Completed |
NCT00484302 -
Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
|
N/A | |
| Completed |
NCT00130923 -
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
|
Phase 4 | |
| Completed |
NCT00455234 -
Rapid Tranquillization Trial: TREC-India II
|
Phase 3 | |
| Completed |
NCT00844922 -
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
|
Phase 2 | |
| Completed |
NCT00128479 -
A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression
|
Phase 3 |