Clinical trial · Interventional
Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers
A Double-blind, Placebo-controlled, Randomized Study of Vortioxetine Treatment on Major Depression, Cognition, and Systemic Inflammatory Biomarkers Associated With Depression and Cancer Progression in Women With Breast Cancer.
NCT02637466CI-TRIAL-00024110withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding not received
Summary
Brief summary (as posted)
The purpose of this antidepressant study is to determine the efficacy of vortioxetine on depression and cognition in 80 women with breast cancer, and to elucidate inflammatory-mediated mechanisms by which depression and its treatment influence cancer outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed women with breast cancer will attenuate increased intermediate endpoints of inflammation that contribute to the pathogenesis of depression, cognitive impairment, and cancer progression
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I, II or III Breast Cancer | — | UNRESOLVED | — |
| Unipolar Major Depression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vortioxetine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vortioxetine
- description
- In cycle I of the study, participants will be randomized on to flexible-dose VTX (10-20 mg) versus. Vortioxetine starting dose will be 10 mg daily. Vortioxetine starting dose will be 10 mg daily with a dose escalation up to 20 mg daily at week #4. Study cycle II is an 8-week, open label treatment design for non-responders completing the Cycle I RCT. One treatment arm will continue VTX non-responders to 8 week VTX (10-20 mg/day) augmentation with cognitive behavioral therapy (10 sessions). The 2nd treatment arm will continue placebo non-responders who complete the RCT to VTX (10 to 20 mg/day). The third treatment arm will continue VTX responders/remitters who complete the RCT to open-label VTX for another 8-weeks to assess maintenance efficacy for up to 16 weeks.
- interventionNames
- Drug: Vortioxetine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- In cycle I of the study, 80 eligible depressed women with breast cancer will be randomized into an 8-week, double-blind, placebo-controlled, flexible-dose vortioxetine (10-20 mg) treatment arm versus placebo arm. Responders to placebo treatment will complete their study participation at the end of Cycle I, and will not proceed to Cycle II.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients 18 to 75 years of age 2. Confirmed diagnosis of Stage I, II, or III breast cancer 3. Completed curative cancer treatment (surgery, chemotherapy, and/or radiotherapy) at least four weeks (≥ 4 weeks) prior to study entry no more than 5 years. 4. Unipolar major depression confirmed by the mood disorder module in Structured Clinical interview for DSM-V (SCID) 5. Baseline depression severity total score ≥18 by Hamilton Depression Rating Scale-21 (HDRS-21) 6. Negative urine pregnancy test in women of child-bearing potential (WOCBP). 7. Use of medically-established contraceptive method (e.g., contraceptive hormone therapy or intrauterine device) in women of child-bearing potential (WOCBP) or abstinence from heterosexual intercourse from the time of signing informed consent through 14 days after the last dose of study drug. 8. Ability to understand and the willingness to sign a written informed consent and HIPAA document/s Exclusion Criteria: * 1\. Other active cancers \[EXCEPTION: cured skin cancer\]. 2. Actively suicidal, as determined by certified mental health provider. 3. Comorbid bipolar disorder or psychosis, as diagnosed by psychiatric clinical interview conducted by a certified mental health provider. 4\. Mini-mental state exam (MMSE) score \<24 at baseline assessment 5. Current use of stimulant and/or amphetamine for cancer-related fatigue or cognitive impairment. 6\. Use of current and effective antidepressants during study period. \[NOTE: Patients who have not responded to current antidepressant may be tapered off medication prior to study entry.\] 7. Uncontrolled hypothyroidism. Must be biochemically (TSH, T3, T4) and clinically euthyroid at baseline assessment. 8\. Use of monoamine oxidase inhibitors (MAOIs) in past 14 days. 9. Concomitant use of mood stabilizer including lithium, lamictal and atypical antipsychotics 10. Failed prior therapy with vortioxetine (VTX) 11. Positive urine toxicology screen for cocaine, opiates, marijuana, amphetamines. 12\. Comorbid alcohol and/or substance use disorder within the prior 12 months of screening, as diagnosed by psychiatric clinical interview conducted by a certified mental health provider.
References
Publications (0)
Data not yet available
No reference posted for this study.