Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • S1RA plus NMDAE

    Drug

    Use of an S1R agonist plus an NMDA enhancer for the treatment of treatment-resistant schizophrenia.

  • S1RA plus Placebo Cap

    Drug

    Use of an S1R agonist plus placebo as a comparator

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: S1R agonist (S1RA) plus NMDAEExperimental treatment 1 intervention
Group B: S1R agonist (S1RA) plus placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
week 0, 2, 4, 6, 8

Secondary outcomes

1

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.

Time frame
week 0, 2, 4, 6, 8
2

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.

Time frame
week 0, 2, 4, 6, 8
3

Clinical Global Impression

Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.

Time frame
week 0, 2, 4, 6, 8
4

Global Assessment of Functioning

Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.

Time frame
week 0, 2, 4, 6, 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

Source ClinicalTrials.gov
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