Schizophrenia
Conditions
Interventions
Experimental group:Maintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 µg/day for 8 weeks. Manufacturer: Merck Serono Ltd.
Control group:The placebo control group will maintain the original antipsychotic regimen, supplemented with a dose-equivalent placebo tablet (starch tablet) matching levothyroxine sodium in appearance
Sponsors
Peking University Sixth Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for schizophrenia according to the International Classification of Diseases, 10th Revision (ICD-10) (World Health Organization, 1993); (2) Aged between 18 and 45 years, right-handed; (3) Currently clinically stable, with the primary antipsychotic medication formulation and dosage unchanged for at least 4 weeks, and a total PANSS score = 16 on the Motivation subscale of the Negative Symptom Assessment (NSA-15) (Zhou et al., 2023), with fewer than 3 items scoring >= 4 and fewer than 2 items scoring >= 5 on the PANSS positive subscale (Rabinowitz et al., 2013); (5) Receiving one or two second-generation antipsychotics (SGAs), with stable medication doses for at least 1 month; (6) Willingness and ability to maintain stable medication doses throughout the trial period; (7) Capacity to understand study procedures, cooperate with all testing requirements, and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Current treatment with first-generation antipsychotics; (2) Current use of thyroid hormone medications or presence of thyroid dysfunction; (3) Hypersensitivity to levothyroxine sodium; or history of non-hypothyroid-related heart failure, tachyarrhythmias, or recent myocardial infarction; (4) Current use of medications known to interact with levothyroxine sodium that may affect its efficacy or safety (e.g., antidiabetic drugs, coumarin derivatives); (5) History of endocrinological or cardiovascular/cerebrovascular diseases; (6) IQ < 80 assessed by the Chinese short-form Wechsler Adult Intelligence Scale (Gong, 1981); (7) History of substance abuse or drug addiction; (8) History of traumatic brain injury or neurological disorders; (9) Receiving electroconvulsive therapy (ECT) within the last 3 months; (10) Pregnancy, lactation, or planning pregnancy within the next 2 months (for female participants); (11) Claustrophobia; implanted metal devices (e.g., prosthetic implants, pacemakers); or other contraindications to MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score of Motivation subscale of the Negative Symptom Assessment (NSA-15) ;Performance of the Effort-Expenditure for Rewards Task (EEfRT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Motivational deficits(avolition) measured by N2 (Emotional Withdrawal) and N4 (Passive/Apathetic, Social Withdrawal) items in the Positive and Negative Syndrome Scale (PANSS).;Performance of the monetary incentive delay task (MID); | — |
Countries
China
Contacts
Public ContactXin Yu
Peking University Sixth Hospital
Outcome results
None listed