Tianeptine for Depression

Recruiting at 3 trial locations

Overseen By Alla Landa, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Jonathan A. Javitch, MD, PhD

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, Opioids

Disqualifiers: Opioid-use disorder, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

38 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants stop taking any current antidepressant, antipsychotic, or mood stabilizer medications. If you are taking one of these medications, you may need to discontinue it under the supervision of your doctor or the study clinician.

What evidence supports the effectiveness of the drug Tianeptine for depression?

Research shows that Tianeptine is effective in treating depression and anxiety, with similar effectiveness to other antidepressants like fluoxetine and amitriptyline. It is particularly beneficial for elderly patients and those recovering from alcohol withdrawal, with fewer side effects compared to some other antidepressants. ^{1 2 3 4 5}

How does the drug Tianeptine differ from other treatments for depression?

Tianeptine is unique because it increases serotonin uptake in the brain, unlike most antidepressants that block serotonin reuptake. It also has fewer sedative and cardiovascular side effects, making it suitable for elderly patients and those with alcohol withdrawal. ^{1 2 4 6 7}

What is the purpose of this trial?

This trial tests tianeptine, an antidepressant that targets specific brain receptors, on adults with major depressive disorder who haven't responded to other treatments. The goal is to see if tianeptine can help these patients by working on the brain's natural painkiller system. Tianeptine is known for its unique way of working and its ability to protect the brain from stress.

Research Team

Alla Landa, PhD

Principal Investigator

New York State Psychiatric Institute

Eligibility Criteria

This trial is for adults aged 21-60 with Major Depressive Disorder who haven't improved after at least two treatments with common antidepressants or other therapies like TMS or ketamine. Participants must be able to consent, follow study procedures, and use contraception if applicable. Exclusions include a history of opioid or severe substance abuse, psychotic disorders, high suicide risk, previous tianeptine treatment, certain medical conditions including severe obesity that affects MRI scanning eligibility.

Inclusion Criteria

I have been diagnosed with Major Depressive Disorder without experiencing psychosis.

If you are a woman who can have a baby, you need to use birth control during the study.

I am between 21 and 60 years old.

Exclusion Criteria

I have been treated with Tianeptine before.

I am currently taking medication for depression, psychosis, or mood stabilization.

I can stop taking certain medications under doctor's advice if needed for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an 8-week treatment trial of tianeptine, including MRI procedures for MSSM patients

8 weeks

Multiple visits (in-person) for treatment and MRI procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Tianeptine Sodium

Trial Overview The trial is testing the effectiveness of Tianeptine Sodium in treating people with Treatment Resistant Depression over an 8-week period. It includes MRI scans for some participants to observe brain changes and genetic tests to find links between genes and depression.

Participant Groups

Group I: Open Treatment Experimental Treatment 1 Intervention

All subjects will be treated for 8 weeks of treatment with Tianeptine (Tianeurax 12.5 mg) 3 times a day (9am, 1pm, 5pm).

Who Is Running the Clinical Trial?

Jonathan A. Javitch, MD, PhD

Lead Sponsor

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Findings from Research

Tianeptine is an effective antidepressant that works differently from most antidepressants by increasing serotonin uptake and reducing stress-induced neuronal damage, with a favorable safety profile that includes minimal cognitive and cardiovascular side effects.

It has shown comparable efficacy to traditional antidepressants like amitriptyline and SSRIs, while also being particularly beneficial for patients with anxiety and those with alcohol dependence, making it a promising option for various subgroups of depressed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tianeptine: a review of its use in depressive disorders. Wagstaff, AJ., Ormrod, D., Spencer, CM.[2018]

Tianeptine is an effective antidepressant that not only shows greater efficacy than placebo but also has similar or superior effects compared to traditional antidepressants like amitriptyline and fluoxetine, particularly in patients with major depression and anxiety.

Tianeptine is well tolerated with fewer side effects compared to amitriptyline, making it a safer option for elderly patients and those recovering from alcohol withdrawal, as it has a lower incidence of common adverse effects like dry mouth and dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tianeptine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depression and coexisting anxiety and depression. Wilde, MI., Benfield, P.[2018]

Tianeptine, an antidepressant not approved by the FDA in the U.S., has been identified as an opioid receptor agonist, leading to concerns about its potential for abuse and severe adverse effects, including death.

From 2000 to 2017, calls to poison control centers regarding tianeptine exposures increased, particularly among individuals aged 21-40, with common symptoms resembling opioid toxicity and withdrawal effects, indicating a growing public health risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Tianeptine Exposures Reported to the National Poison Data System - United States, 2000-2017. El Zahran, T., Schier, J., Glidden, E., et al.[2018]

Tianeptine has been shown to be effective in treating depressive disorders, with 78% of patients responding positively to treatment, as evidenced by both clinical rating scales and patient feedback.

In addition to its antidepressant effects, tianeptine also alleviates anxiety symptoms and somatic complaints, making it a versatile option for patients experiencing a range of depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant and anxiolytic activities of tianeptine: an overview of clinical trials. Defrance, R., Marey, C., Kamoun, A.[2014]

Tianeptine is a unique antidepressant that not only alleviates depression but also reduces anxiety without causing sedation or impairing memory, making it different from traditional benzodiazepines.

It works by enhancing serotonin uptake and improving hippocampal activity, which may contribute to its effects on memory and stress adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tianeptine, an uncommon psychotropic drug]. Kamoun, A., Labrid, C., Mocaër, E., et al.[2014]

In a year-long multicenter trial with 380 depressed patients, tianeptine significantly reduced depression scores from day 14 and maintained this improvement for up to 12 months, indicating its efficacy as an antidepressant.

The treatment was well-tolerated, with only 11% of patients withdrawing due to depression recurrence and 2% due to side effects, which were generally mild, suggesting that tianeptine is a safe option for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of tianeptine in 380 depressed patients. Lôo, H., Ganry, H., Dufour, H., et al.[2014]

In a study involving 55 patients with recurrent depressive disorder, tianeptine showed high preventive efficacy, with 61% of patients achieving full response and 74% showing overall improvement after 12 months of treatment.

Tianeptine was well tolerated, with only mild side effects reported, indicating it is a safe option for long-term management of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preventive efficacy of tianeptine in recurrent depression with frequent exacerbations]. Mosolov, SN., Vertogradova, OP., Panteleeva, GP., et al.[2016]

References

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

Tianeptine: a review of its use in depressive disorders. [2018]

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

Tianeptine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depression and coexisting anxiety and depression. [2018]

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

Characteristics of Tianeptine Exposures Reported to the National Poison Data System - United States, 2000-2017. [2018]

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

Antidepressant and anxiolytic activities of tianeptine: an overview of clinical trials. [2014]

5. France pubmed.ncbi.nlm.nih.gov

[Tianeptine, an uncommon psychotropic drug]. [2014]

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

Long-term use of tianeptine in 380 depressed patients. [2014]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Preventive efficacy of tianeptine in recurrent depression with frequent exacerbations]. [2016]