Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
NCT Number: NCT06574360
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Schizophrenia
Interventions: DRUG: S1RA plus NMDAE|DRUG: S1RA plus Placebo Cap
Sponsor: China Medical University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-03
Locations: Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan

Summary:
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.

Primary Outcome Measures: Change of Positive and Negative Syndrome Scale (PANSS), Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome., week 0, 2, 4, 6, 8
Secondary Outcome Measures: Change of scales for the Assessment of Negative Symptoms (SANS) total score, Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome., week 0, 2, 4, 6, 8|Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS, PANSS-positive: Assessment of positive symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome.

PANSS-negative: Assessment of negative symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome.

PANSS-general psychopathology: Assessment of general psychopathology. Minimum value: 16, maximum value:112, the higher scores mean a worse outcome., week 0, 2, 4, 6, 8|Clinical Global Impression, Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome., week 0, 2, 4, 6, 8|Global Assessment of Functioning, Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function., week 0, 2, 4, 6, 8|Quality of Life Scale, Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome., week 0, 2, 4, 6, 8|Cognitive function, Ten tests for assessment of 7 cognitive domains:

1. speed of processing (assessed by Category Fluency, Trail Marking A, Wechsler Adult Intelligence Scale(WAIS)-III Digit Symbol-Coding)
2. sustained attention (Continuous Performance Test)
3. working memory: verbal (digit span) and nonverbal (spatial span)
4. verbal learning and memory (WMS-III, word listing)
5. visual learning and memory (WMS-III, visual reproduction)
6. reasoning and problem solving (WISC-III, Maze)
7. social cognition (MSCEIT Version 2)

For the domain (a. and c.) with more than one test, a composite T score will be calculated by standardizing the average of each T score. Furthermore, a global composite score (for all seven domains) and a neurocognitive composite score (for the first 6 domains) will be also calculated by standardizing the average of the T score (Lane HY et al, JAMA Psychiatry 2013), Week 0, 8