Clinical trial · Interventional
Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment
Prevention of Depression in Patients Being Treated for Head and Neck Cancer
NCT00536172CI-TRIAL-00069727PROTECTcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escitalopram | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escitalopram
- description
- Participants will receive treatment with escitalopram
- interventionNames
- Drug: Escitalopram
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive treatment with placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)
- timeFrame
- Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed or recurrent epidermoid cancer of the head and neck * Requires more than minimal therapy for treatment * Able to read and write in English * Willing to use an effective form of birth control throughout the study Exclusion Criteria: * Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores 24 or less * Suicidal or psychotic * Current allergy or hypersensitivity to citalopram or other SSRIs * Treated with monoamine oxidase inhibitors 14 days prior to study entry * Use of antidepressants within 1 week of study entry * Pregnant or breastfeeding * History of an adequate cancer operation, radiation, or chemotherapy within 6 months of study entry * Diagnosed with melanoma or lymphoma cancer of the head and neck * Currently participating in another research study involving a therapeutic intervention
References
Publications (2)
- RESULTLydiatt WM, Bessette D, Schmid KK, Sayles H, Burke WJ. Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):678-86. doi: 10.1001/jamaoto.2013.3371. PMID 23788218
- DERIVEDVita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4. PMID 36999619