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Study · Non-randomized trial · n = 5 · 2025

6 results

Indications for an antidepressive effect of thymosin alpha-1 in a small open-label proof of concept study in common variable immune deficiency patients with depression.

Aynekulu Mersha DG, Fromme SE, van Boven F, Arteaga-Henríquez G, Wijkhuijs A, van der Ent M, Bergmans R, Baune BT, Drexhage HA, Dalm V

Brain, behavior, & immunity - health2 Jan 2025Cited by 3 (Europe PMC)

PMID39867848 (opens in a new tab)PMCIDPMC11762651 (opens in a new tab)DOI10.1016/j.bbih.2024.100934 (opens in a new tab)PepBankPUB-39867848
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Summary

BackgroundA considerable proportion (21%) of patients with common variable immunodeficiency (CVID) suffers from depression. These subjects are characterized by reduced naïve T cells and a premature T cell senescence similar to that of patients with major depressive disorder (MDD). It is known that T cells are essential for limbic system development/function. Treatment with thymosin α1 (Tα1) is capable to increase the thymus output of naïve T cells.ObjectiveTo treat CVID patients with a comorbid depressive episode with Tα1 to increase naïve T cells and thereby improve mood.DesignA small open-label, proof of concept trial. Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly). At the start, at 8 weeks and 8 weeks after the last injection, the HDRS was recorded and blood samples drawn for measuring naïve and memory T cells, Th17 and Treg cells, hsCRP, IL-6 and IL-7. Outcomes were compared to those of a contrast group (42 MDD patients, same severity but treated as usual (TAU)).ResultsIn all 5 depressed CVID patients HDRS decreased during Tα1 treatment (with average 52%, TAU decreased scores with 36% in MDD patients). All 5 CVID patients showed an increase in naïve/memory CD4+ and CD8+ T cell ratios, and in 4 of the 5 patients with detectable IL-6 levels reductions were recorded. TAU did not show such immune improvements. In the 8-week wash-out, depression recurred in the 2 most severe patients, while continued to improve in the others. Immune effects were not sustained in the wash-out.ConclusionThis preliminary small study suggests thymus hormone treatment to have antidepressive and related immune correcting effects. Data urge for larger placebo-controlled trials.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In depressed CVID patients, HDRS scores fell by an average of 52% during Tα1 treatment, against 36% with treatment as usual in MDD patients.

    In plain wordsIn five depressed patients with immune deficiency, depression scores fell by 52% on thymosin alpha‑1, against 36% in a different group treated as usual.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseHamilton Depression Rating Scale score
    Study

    n = 5

    Comparator
    TAU in 42 MDD patients
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Measurements

    HDRS decrease
    52%
    Tα1, CVID patients
    HDRS decrease
    36%
    TAU, MDD patients

    Source sentences

    Summary
    In all 5 depressed CVID patients HDRS decreased during Tα1 treatment (with average 52%, TAU decreased scores with 36% in MDD patients).
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).
  2. 02HumanNon-randomized trialEfficacy outcome

    In depressed CVID patients, all 5 showed an increase in the naive/memory CD4+ T cell ratio during Tα1 treatment.

    In plain wordsIn five patients with immune deficiency, thymosin alpha‑1 raised the ratio of naive to memory CD4 T cells in all five.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseNaive/memory CD4+ T cell ratio
    Study

    n = 5

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    All 5 CVID patients showed an increase in naïve/memory CD4+ and CD8+ T cell ratios
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).
  3. 03HumanNon-randomized trialEfficacy outcome

    In depressed CVID patients, all 5 showed an increase in the naive/memory CD8+ T cell ratio during Tα1 treatment.

    In plain wordsIn five patients with immune deficiency, thymosin alpha‑1 raised the ratio of naive to memory CD8 T cells in all five.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseNaive/memory CD8+ T cell ratio
    Study

    n = 5

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    All 5 CVID patients showed an increase in naïve/memory CD4+ and CD8+ T cell ratios
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).
  4. 04HumanNon-randomized trialEfficacy outcome

    In the 8-week wash-out after Tα1, depression recurred in the 2 most severe CVID patients and kept improving in the others.

    In plain wordsAfter thymosin alpha‑1 stopped, depression returned in the two most severe of five patients and kept improving in the other three.

    Peptide
    Thymosin alpha-1
    Outcome
    MixedDepression after 8-week wash-out
    Study

    n = 5

    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    In the 8-week wash-out, depression recurred in the 2 most severe patients, while continued to improve in the others.
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).
  5. 05HumanNon-randomized trialEfficacy outcome

    In CVID patients, the immune effects of Tα1 were not sustained during the 8-week wash-out.

    In plain wordsIn five patients with immune deficiency, the immune changes seen on thymosin alpha‑1 did not last after treatment stopped.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeImmune effects after 8-week wash-out
    Study

    n = 5

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Immune effects were not sustained in the wash-out.
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).
  6. 06HumanNon-randomized trialEfficacy outcome

    In 4 of the 5 CVID patients with detectable IL-6 levels, IL-6 fell during Tα1 treatment.

    In plain wordsIn four of the five patients with immune deficiency, thymosin alpha‑1 treatment came with lower IL-6.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseIL-6 level
    Study

    n: not reported in source

    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    1.6 mg daily in week 1, then 1.6 mg twice weekly · subcutaneous · 8 weeksAs given in this study (human).

    Measurements

    Patients with IL-6 reduction
    4 patients
    of 5 with detectable IL-6

    Source sentences

    Summary
    and in 4 of the 5 patients with detectable IL-6 levels reductions were recorded.
    2 context sentences
    Summary · context
    A small open-label, proof of concept trial.
    Summary · context
    Five depressed CVID patients (Hamilton Depression Rating Scale, HDRS >12) could be treated with Tα1 (8 weeks, 1.6 mg daily subcutaneously, 1st week, thereafter 1.6 mg twice weekly).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    10 Oct 2026, 08:19 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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