Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital
About this trial
sigma-1 receptor (S1R) agonistic property have been tested in clinical trials for the treatment of schizophrenia. In addition, previous studies found that some NMDA receptor (NMDAR)-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. Whether combined treatment of an S1R agonist and an NMDA-enhancing agent can be better than an S1R agonist alone deserves study.
Eligibility criteria
Qualifiers
Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
Are resistant to adequate treatments of at least two antipsychotics (excluding clozapine)
Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 8-week trial
PANSS total score >70
Disqualifiers
DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
History of epilepsy, head trauma, central nervous system diseases or mental disorders other than schizophrenia (including major depressive disorder, bipolar disorders, persistent depressive disorder, obsessive-compulsive disorder)
Pregnancy or lactation
Inability to follow protocol
Trial design
Treatments tested in this trial
- S1RA plus NMDAE
- S1RA plus Placebo Cap
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov