ABX-002 for Depression

Recruiting at -1 trial locations

Overseen By Ashlee Heldreth, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Autobahn Therapeutics, Inc.

Must be taking: SSRIs, SNRIs

Must not be taking: Psychedelics, MAOIs, TCAs, others

Disqualifiers: Schizophrenia, Bipolar, Epilepsy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, Treatment, and Follow-Up ; approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period

Will I have to stop taking my current medications?

You will need to continue taking your current antidepressant medication as it is part of the study. However, you cannot use other medications like certain augmentation agents, biotin, or drugs affecting liver enzymes during the trial.

What data supports the effectiveness of the drug ABX-002 for depression?

Research on similar drugs like brexpiprazole and aripiprazole, which are used as additional treatments for depression, shows they can improve symptoms when standard antidepressants aren't enough. These drugs have been found to help reduce depression scores and improve overall functioning in patients. ^{1 2 3 4 5}

How does the drug ABX-002 for depression differ from other treatments?

ABX-002 may involve a novel combination of components similar to the synergistic effects seen with low doses of fluoxetine (an antidepressant) and estradiol (a form of estrogen), which together enhance antidepressant-like effects and promote brain cell growth in animal studies. This suggests ABX-002 might work differently by potentially combining elements that target both mood improvement and brain health. ^{6 7 8 9 10}

Eligibility Criteria

Adults with moderate to severe major depressive disorder who haven't had enough improvement from their current antidepressant can join this study. They must pass a screening and be okay with being randomly assigned to receive either ABX-002 or a placebo.

Inclusion Criteria

Are you currently taking Antidepressant medication?

Exclusion Criteria

Have you been diagnosed with Schizophrenia?

Have you been diagnosed with Psychosis?

Have you been diagnosed with Bipolar Disorder?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Approximately 5 weeks

Treatment

Participants receive ABX-002 or placebo in addition to their stable dose of SSRI/SNRI antidepressants

6 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• ABX-002 (Behavioural Intervention)

Trial Overview The AMPLIFY trial is testing if adding ABX-002 to standard antidepressants helps improve symptoms in those not responding well to treatment. Participants will be blindly given either ABX-002 or a fake drug (placebo) for comparison over six weeks, followed by safety checks.

Participant Groups

Group I: ABX-002 + SSRI/SNRI Experimental Treatment 1 Intervention

Patients continue to receive their selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study in addition to ABX-002.

Group II: Placebo + SSRI/SNRI Placebo Group 1 Intervention

Patients continue to receive their selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study in addition to the Placebo.

Who Is Running the Clinical Trial?

Autobahn Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

310+

Findings from Research

Brexpiprazole, at doses of 2-3 mg/day, significantly improved depression symptoms in adults with major depressive disorder who did not respond adequately to previous antidepressant treatments, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).

The treatment was generally well tolerated, with common side effects including akathisia, somnolence, and headache, but no unexpected adverse effects were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of flexibly dosed brexpiprazole for the adjunctive treatment of major depressive disorder: a randomized, active-referenced, placebo-controlled study. Hobart, M., Skuban, A., Zhang, P., et al.[2019]

In a study involving 2944 adult patients with major depressive disorder (MDD), adjunctive treatment with brexpiprazole for up to 52 weeks was generally well tolerated, with most treatment-emergent adverse events (TEAEs) being mild to moderate in severity.

Patients experienced continuous improvement in depressive symptoms and functioning, with a mean weight increase of 3.2 kg over the study period, but no significant issues related to extrapyramidal symptoms or metabolic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder. Hobart, M., Zhang, P., Skuban, A., et al.[2020]

In two large trials involving adults with major depressive disorder who did not respond adequately to standard antidepressants, adjunctive treatment with aripiprazole (2-20 mg/day) significantly improved depression scores compared to placebo, starting from 1-2 weeks into treatment.

Aripiprazole was generally well tolerated, with most side effects being mild to moderate, and it also led to higher rates of response and remission compared to placebo, indicating its efficacy as an adjunctive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aripiprazole: in major depressive disorder. Weber, J., Lyseng-Williamson, KA., Scott, LJ.[2021]

The bushen tiaogan qingxin recipe (BTQR) was found to be significantly more effective than hormone replacement therapy (HRT) in treating climacteric depression, with an effective rate of 87.2% compared to 67.3% in the control group.

BTQR appears to work by regulating neurotransmitter levels (decreasing serotonin and increasing norepinephrine) and adjusting reproductive hormone levels, which may help improve mood and overall endocrine function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on treatment of climacteric depression with bushen tiaogan qingxin recipe]. He, JQ., Tang, XW., Chen, HX., et al.[2016]

In male rats, the antidepressant effects of fluoxetine (FLX) and desipramine (DMI) are influenced by testosterone levels, as orchidectomy (removal of testes) reduces these effects, which can be partially restored by testosterone.

The study found that estrogen, particularly 17beta-estradiol (E2), plays a significant role in enhancing the antidepressant effects of DMI and FLX, especially in orchidectomized rats, suggesting that estrogens may be important for the efficacy of these antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estrogens participate in the antidepressant-like effect of desipramine and fluoxetine in male rats. Martínez-Mota, L., Cruz-Martínez, JJ., Márquez-Baltazar, S., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of flexibly dosed brexpiprazole for the adjunctive treatment of major depressive disorder: a randomized, active-referenced, placebo-controlled study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adjunctive aripiprazole in major depressive disorder in older patients: a pooled subpopulation analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Global benefit-risk analysis of adjunctive aripiprazole in the treatment of patients with major depressive disorder. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Aripiprazole: in major depressive disorder. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effect of sub-optimal doses of fluoxetine plus estradiol on antidepressant-like behavior and hippocampal neurogenesis in ovariectomized rats. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Study on treatment of climacteric depression with bushen tiaogan qingxin recipe]. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

The oral dose-effect relationship for fluvoxamine: a fixed-dose comparison against placebo in depressed outpatients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Estrogens participate in the antidepressant-like effect of desipramine and fluoxetine in male rats. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Synergistic interaction between ketoconazole and several antidepressant drugs with allopregnanolone treatments in ovariectomized Wistar rats forced to swim. [2013]