Trial Outcomes & Findings for Tianeptine for Treatment Resistant Depression (NCT NCT04249596)

Last Updated: 2026-01-23

Results Overview

Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-01-23

Participant Flow

Participants were recruited from outpatient clinics at three academic medical centers: New York State Psychiatric Institute, Icahn School of Medicine at Mount Sinai, and Stanford University. Recruitment occurred from October 2020 to August 2024. Study was terminated early due to inadequate recruitment (38 of 75 target enrolled).

Baseline assessments (HAMD-24, ARSQ) were performed prior to treatment initiation. Participants on antidepressants completed a taper period before baseline. Some participants who consented did not initiate treatment due to screen failure, consent withdrawal, or loss to follow-up during the screening period. Per protocol, enrollment was defined as initiation of study medication; participants who did not receive study drug were not considered enrolled.

Participant milestones

Participant milestones
Measure	Tianeptine Sodium 12.5mg TID Treatment Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Overall Study STARTED	38
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Tianeptine Sodium 12.5mg TID Treatment Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	3

Baseline Characteristics

Tianeptine for Treatment Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tianeptine Sodium 12.5mg TID Treatment n=38 Participants Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Age, Continuous	37.2 Years STANDARD_DEVIATION 10.5 • n=270 Participants
Sex/Gender, Customized Female	23 Participants n=270 Participants
Sex/Gender, Customized Male	14 Participants n=270 Participants
Sex/Gender, Customized Non-binary	1 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	5 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	2 Participants n=270 Participants
Race (NIH/OMB) White	24 Participants n=270 Participants
Race (NIH/OMB) More than one race	4 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=270 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=270 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=270 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=270 Participants
Baseline HAMD-24 Score	25.4 units on a scale STANDARD_DEVIATION 5.8 • n=270 Participants
Baseline ARSQ Score	14.6 units on a scale STANDARD_DEVIATION 5.3 • n=270 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants who completed 8-week treatment protocol (30 of 38 who started)

Outcome measures

Outcome measures
Measure	Tianeptine Sodium 12.5mg TID Treatment n=30 Participants Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Hamilton Rating Scale for Depression, 24-item (HAMD-24)	-5.2 units on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants who completed 8-week treatment protocol (30 of 38 who started)

Proportion of participants achieving ≥50% reduction in HAMD-24 score from baseline

Outcome measures

Outcome measures
Measure	Tianeptine Sodium 12.5mg TID Treatment n=30 Participants Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Response Rate	7 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants who completed 8-week treatment protocol (30 of 38 who started)

Proportion of participants achieving HAMD-24 score ≤10 at Week 8

Outcome measures

Outcome measures
Measure	Tianeptine Sodium 12.5mg TID Treatment n=30 Participants Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Remission Rate	6 Participants

Adverse Events

Tianeptine Sodium 12.5mg TID Treatment

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tianeptine Sodium 12.5mg TID Treatment n=38 participants at risk Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Psychiatric disorders Depression worsening requiring hospitalization	2.6% 1/38 • 8 weeks Adverse events were assessed at each study visit using systematic inquiry

Other adverse events

Other adverse events
Measure	Tianeptine Sodium 12.5mg TID Treatment n=38 participants at risk Open-label tianeptine sodium 12.5mg three times daily for 8 weeks
Nervous system disorders Headache	5.3% 2/38 • 8 weeks Adverse events were assessed at each study visit using systematic inquiry
Nervous system disorders Somnolence	7.9% 3/38 • 8 weeks Adverse events were assessed at each study visit using systematic inquiry

Additional Information

Jonathan A. Javitch, MD, PhD

New York State Psychiatric Instittue

Phone: 646-774-8600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place