Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
ConditionProdromal Schizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-45
SponsorChina Medical University Hospital
About this trial
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration).
Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms [SOPS] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period.
Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period.
Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject < 20 years old, a parent also has to provide written informed consent.
Disqualifiers
DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition.
History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study.
Clinically significant laboratory screening tests (including blood routine, biochemical tests)
Pregnancy or lactation
Trial design
Design model
Parallel
Treatments tested in this trial
NMDAE
DrugUse of an NMDA enhancer for the treatment of prodromal schizophrenia .
Placebo Cap
DrugUse of placebo as a comparator
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: NMDAEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Scale of Prodromal Symptoms [SOPS] total score
Assessment of overall prodromal symptoms. Minimum value: 0, maximum value: 114, the higher scores mean a worse outcome. As shown in "Detailed Description", "mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). That is, GEE is used for analyzing the changes from baseline in repeated-measure assessments by a single analysis (but not multiple analyses).
Time frame
week 0, 2, 4, 6, 9, 12Secondary outcomes
1
Change from baseline in SOPS Positive Symptom Scale score
Assessment of positive prodromal symptoms. Minimum value: 0, maximum value: 30, the higher scores mean a worse outcome.
Time frame
week 0, 2, 4, 6, 9, 122
Change from baseline in SOPS Negative Symptom Scale score
Assessment of negative prodromal symptoms. Minimum value: 0, maximum value: 36, the higher scores mean a worse outcome.
Time frame
week 0, 2, 4, 6, 9, 123
Change from baseline in SOPS Disorganization Symptom Scale score
Assessment of disorganization prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Time frame
week 0, 2, 4, 6, 9, 124
Change from baseline in SOPS General Symptom Scale score
Assessment of general prodromal symptoms. Minimum value: 0, maximum value: 24, the higher scores mean a worse outcome.
Time frame
week 0, 2, 4, 6, 9, 12Sponsors and contacts
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Source ClinicalTrials.gov