NCT07011953

A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate whether adjunctive thyroxine treatment can ameliorate motivation deficits in adults with schizophrenia experiencing predominant avolition (core negative symptom). The main questions it aims to answer are: * Does adjunctive thyroxine reduce avolition symptoms compared to placebo? * Does adjunctive thyroxine normalize cortico-striatal circuit activity during reward processing? Researchers will compare the treatment group (adjunctive sodium tablets, 50μg/day) with the control group (dose-equivalent placebo starch tablet) to see if thyroid hormone: 1. Significantly improves clinical scores of avolition 2. Modulates neural activation in motivation-processing brain circuits Participants will: * Maintain stable antipsychotic therapy for 8 weeks * Receive daily levothyroxine/placebo tablets * Complete the following assessments pre-/post-treatment: * Clinical evaluations (PANSS, NSA, PSP) * MRI scans (resting-state, structural, fMRI during reward tasks) * Blood tests * Behavioral motivation tasks

Conditions

• Schizophrenia
• Avolition

Interventions

Type	Name	Description
DRUG	Antipsychotics plus Levothyroxine Sodium	Maintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 μg/day for 8 weeks. Manufacturer: Merck Serono Ltd. Levothyroxine Sodium Tablets should be administered as a single daily dose on an empty stomach, 30 minutes before breakfast, with sufficient liquid (e.g., half a glass of water).
DRUG	Antipsychotics plus Placebo	All participants maintain pre-study antipsychotic medication at stable doses. ADDITIONALLY, they receive a visually identical placebo tablet. Placebo characteristics \& Blinding guaranteet: Matches levothyroxine in appearance (size/color/coating), taste, and packaging. Active ingredien : starch tablet with no biological activity. Administration: Once daily in the morning under identical fasting conditions.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-06-10
• Last updated: 2025-06-10