SchizophreniaEarly Phase 1NCT07011953
A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia
A Early Phase 1 study testing Antipsychotics plus Levothyroxine Sodium in people with Schizophrenia and Avolition, run by Peking University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Avolition
- What is being tested?
- Antipsychotics plus Levothyroxine Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
- Capacity to understand study procedures, cooperate with all testing requirements, and provide written informed consent.
Who cannot join
- 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);
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- History of substance abuse or drug addiction;
- History of traumatic brain injury or neurological disorders;
- Receiving electroconvulsive therapy (ECT) within the last 3 months;
- Pregnancy, lactation, or planning pregnancy within the next 2 months (for female participants);
- Claustrophobia; implanted metal devices (e.g., prosthetic implants, pacemakers); or other contraindications to MRI scanning.
About this study
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:
Read more
- 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:
- Significantly improves clinical scores of avolition
- 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
- Being tested
- Antipsychotics plus Levothyroxine Sodium, Antipsychotics plus Placebo
- Keywords
- schizophrenia, avolition, thyroxine, double blind, randomized controlled trial, motivation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotics plus Levothyroxine SodiumDrug
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).
Antipsychotics plus PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: adjunctive thyroxine | Experimental | Maintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 μg/day for 8 weeks. Manufacturer: Merck Serono Ltd. Receives: Drug: Antipsychotics plus Levothyroxine Sodium |
| Placebo Control group | Placebo comparator | The placebo control group will maintain the original antipsychotic regimen, supplemented with a dose-equivalent placebo tablet (starch tablet) matching levothyroxine sodium in appearance and nominal dosage (50 μg/day) for 8 weeks. Manufacturer: Boji Medical Technology Co., Ltd. Receives: Drug: Antipsychotics plus Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of Motivation subscale of the Negative Symptom Assessment (NSA-15)
Measured: Baseline, 2-week follow-up, 4-week follow-up, 6-week follow-up, 8-week follow-up
Secondary outcomes (3)
Motivational deficits(avolition) measured by N2 (Emotional Withdrawal) and N4 (Passive/Apathetic, Social Withdrawal) items in the Positive and Negative Syndrome Scale (PANSS).
Measured: Baseline, 2-week follow-up, 4-week follow-up, 6-week follow-up, 8-week follow-up
Performance of the monetary incentive delay task (MID)
Measured: baseline, 8-week follow-up
Performance of the Effort-Expenditure for Rewards Task (EEfRT)
Measured: baseline, 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Yu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011953
- Sponsor's protocol ID
- 2025-06-02
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Adjunctive Thyroxine for Avolition in Schizophrenia
- ClinicalTrials.gov ID
- NCT07011953
- Acronym / sponsor ID
- 2025-06-02
- Conditions
- Schizophrenia, Avolition
- Keywords
- schizophrenia, avolition, thyroxine, double blind, randomized controlled trial, motivation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Significantly improves clinical scores of avolition
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group: adjunctive thyroxine | Experimental | Drug: Antipsychotics plus Levothyroxine SodiumMaintain the original antipsychotic regimen combined with levothyroxine sodium tablets (Euthyrox), 50 μg/day for 8 weeks. Manufacturer: Merck Serono Ltd. |
| Placebo Control group | Placebo comparator | Drug: Antipsychotics plus PlaceboThe placebo control group will maintain the original antipsychotic regimen, supplemented with a dose-equivalent placebo tablet (starch tablet) matching levothyroxine sodium in appearance and nominal dosage (50 μg/day) for 8 weeks. Manufacturer: Boji Medical Technology Co., Ltd. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipsychotics plus Levothyroxine SodiumMaintain 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 | Treatment group: adjunctive thyroxine |
| Antipsychotics plus PlaceboAll 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. | Drug | Placebo Control group |
Primary outcome
the score of Motivation subscale of the Negative Symptom Assessment (NSA-15)
Time frame: Baseline, 2-week follow-up, 4-week follow-up, 6-week follow-up, 8-week follow-up
3 secondary outcomes
Motivational deficits(avolition) measured by N2 (Emotional Withdrawal) and N4 (Passive/Apathetic, Social Withdrawal) items in the Positive and Negative Syndrome Scale (PANSS).
Time frame: Baseline, 2-week follow-up, 4-week follow-up, 6-week follow-up, 8-week follow-up
Performance of the monetary incentive delay task (MID)
Time frame: baseline, 8-week follow-up
Performance of the Effort-Expenditure for Rewards Task (EEfRT)
Time frame: baseline, 8-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Antipsychotics plus Levothyroxine Sodium in people with Schizophrenia and Avolition, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Motivation subscale of the Negative Symptom Assessment (NSA-15) (time frame: Baseline, 2-week follow-up, 4-week follow-up, 6-week follow-up, 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.