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Monotherapy of an NMDA Enhancer for Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital

About this trial

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia

Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects

PANSS total score ≥ 60

Free of antipsychotic drugs for at least 1 week

Disqualifiers

Current substance abuse or history of substance dependence in the past 3 months

History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study

Use of depot antipsychotic in the past 3 months;

Clinically significant laboratory screening tests

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMDAE

    Drug

    Use of an NMDA enhancer for the treatment of schizophrenia

  • Placebo Cap

    Drug

    Use of placebo as a comparator

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: NMDAEExperimental treatment 1 intervention
Group B: 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
2

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

Secondary outcomes

1

Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (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
2

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
3

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
4

Hamilton Rating Scale for Depression

Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.

Time frame
week 0, 2, 4, 6

Other outcomes

Sponsors and contacts

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

China Medical University Hospital

Lead sponsor

National Health Research Institutes, Taiwan

Collaborator

Source ClinicalTrials.gov
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