Combining two treatments for schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a combined treatment approach using a sigma-1 receptor agonist and an NMDA receptor enhancer for patients with treatment-resistant schizophrenia. Participants will be randomly assigned to receive either the combination treatment or a placebo while maintaining their current antipsychotic medications. The study will assess clinical performance and side effects over a 12-week period, with cognitive functions evaluated at the beginning and end of the treatment. The goal is to determine if the combination therapy offers greater benefits than the sigma-1 receptor agonist alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Hamilton Depression Rating Scale-17 items (HAMD) \<7
* Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant.
* Have sufficient education to communicate effectively and are capable of completing the assessments of the study.
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* 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

Where it's running

• Department of Psychiatry, China Medical University Hospital
  Taichung, Taiwan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.