A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia (NCT07011953) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia
90 participantsStarted 2025-07-01
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Meet the diagnostic criteria for schizophrenia according to the International Classification of Diseases, 10th Revision (ICD-10) (World Health Organization, 1993);
. Aged between 18 and 45 years, right-handed;
. Currently clinically stable, with the primary antipsychotic medication formulation and dosage unchanged for at least 4 weeks, and a total PANSS score ≤ 60;
. Predominant avolition symptoms, defined as a 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);
. Receiving one or two second-generation antipsychotics (SGAs), with stable medication doses for at least 1 month;
. Willingness and ability to maintain stable medication doses throughout the trial period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the score of Motivation subscale of the Negative Symptom Assessment (NSA-15)
. Capacity to understand study procedures, cooperate with all testing requirements, and provide written informed consent.
Exclusion criteria
. Current treatment with clozapine or first-generation antipsychotics;
. Current use of thyroid hormone medications or presence of thyroid dysfunction;
. Hypersensitivity to levothyroxine sodium; or history of non-hypothyroid-related heart failure, tachyarrhythmias, or recent myocardial infarction;
. Current use of medications known to interact with levothyroxine sodium that may affect its efficacy or safety (e.g., antidiabetic drugs, coumarin derivatives);
. History of endocrinological or cardiovascular/cerebrovascular diseases;
. IQ \< 80 assessed by the Chinese short-form Wechsler Adult Intelligence Scale (Gong, 1981);
. History of substance abuse or drug addiction;
. History of traumatic brain injury or neurological disorders;