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A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia

NCT07011953 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011953 on ClinicalTrials.gov