Effectiveness Not Established

COX-2 Inhibitors

for Depression

COX-2 inhibitors are a type of nonsteroidal anti-inflammatory drug that directly affects COX-2, an enzyme involved in inflammation and associated pain. The use of COX-2 inhibitors was evaluated in patients with cancer related to the development of palmar-plantar erythrodysesthesia (PPE) skin effects and as a potential treatment for oral mucositis. Celecoxib, a type of COX-2 inhibitor, has also been studied for its impact on symptoms of depression in patients with cancer.

Research Evidence Summaries

Alamdarsaravi, M., Ghajar, A., Noorbala, A.A., Arbabi, M., Emami, A., Shahei, F., . . . Akhondzadeh, S. (2017). Efficacy and safety of celecoxib monotherapy for mild to moderate depression in patients with colorectal cancer: A randomized double-blind, placebo controlled trial. Psychiatry Research, 255, 59–65.

Study Purpose

To assess the safety and efficacy of celecoxib single therapy on depressive symptoms of patients with colorectal cancer who underwent chemotherapy.

Intervention Characteristics/Basic Study Process

Parallel-group, randomized, double-blind, placebo-controlled trial, randomized to either 400 mg per day celecoxib or placebo for 6 weeks.

Sample Characteristics

  • N = 40
  • AGE: 18-65 years
  • MALES: 65% in celecoxib arm; 55% in placebo arm  
  • FEMALES: Not listed
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage I–IV colorectal cancer diagnosed more than 100 days 
  • OTHER KEY SAMPLE CHARACTERISTICS: 15% in celecoxib group and 20% in placebo group reported past psychiatry history

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Tehran University of Medical Sciences, Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Parallel-group, randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

Hamilton Depression Rating Scale, Visual Analog Scale to measure pain intensity, at week 2, 4, and 6 post-treatment. Adverse events were evaluated at each point using a checklist. Medication adherence was measured with weekly capsule counts with participant reports of medication intake.

Results

HRDS scores were significantly greater in the celecoxib treatment group at week 2 and remained higher until week 6 (p = 0.028). There was not a significant difference between mean VAS scores between the groups at week 2, 4, and 6 (p = 0.459). Gastrointestinal side effects that have been attributed to celecoxib, such as abdominal pain and diarrhea, were not significantly different between the intervention groups. No symptoms of cardiovascular adverse event or serious adverse event occurred.

Conclusions

Celecoxib monotherapy is potentially safe and effective treatment for mild to moderate depression in patients with colorectal cancer undergoing chemotherapy.

Limitations

Small sample (< 100)

Nursing Implications

Oncology nurses are in a key position to screen for psychological distress in patients undergoing chemotherapy. Celecoxib has been shown in this study to be effective for mild to moderate depression in patients with colorectal cancer. Celecoxib may also be effective in patients with other malignancies although further research is needed. Oncology nurses should discuss with physicians the use of celecoxib for any patients with colorectal cancer exhibiting mild to moderated depression as evidenced on psychological distress screening.

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Mohammadinejad, P., Arya, P., Esfandbod, M., Kaviani, A., Najafi, M., Kashani, L., . . . Akhondzadeh, S. (2015). Celecoxib versus diclofenac in mild to moderate depression management among breast cancer patients: A double-blind, placebo-controlled, randomized trial. Annals of Pharmacotherapy, 49, 953–961.

Study Purpose

To compare celecoxib versus diclofenac in mild to moderate depression in patients with breast cancer

Intervention Characteristics/Basic Study Process

Patients with breast cancer with mild to moderate depression and pain were randomized to receive celecoxib or diclofenac over a six-week period. Depression was evaluated at baseline, three weeks, and six weeks.

Sample Characteristics

  • N = 52
  • MEAN AGE: 18-70 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients had breast cancer for more than 100 days; major depression according to ​Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), 4th edition; a score of less than or equal to 18 on the Hamilton Depression Rating Scale (HDRS); and mild to moderate pain, and needed an analgesic.
  • OTHER KEY SAMPLE CHARACTERISTICS: No other psychotropic medication and no behavioral intervention therapy.

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient
  • LOCATION: Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care 

Study Design

  • Single center, double-blind, controlled, parallel group

Measurement Instruments/Methods

  • DSM-IV-TR to diagnose
  • HDRS
  • Visual Analog Scale (VAS) mild to moderate pain (0-100) measured by need for analgesic

Results

Fifty-two patients randomized with similar characteristics showed a significant reduction in HDRS score in celecoxib group by week six; however, none achieved a remission of symptoms. There was no significant difference in VAS score.

Conclusions

There was a greater antidepressant effect for celecoxib than for diclofenac by week 6.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no control group)
  • Findings not generalizable
  • Very short time frame; metastatic disease may have had an effect on results due to pain and prognosis

Nursing Implications

It is important to recognize that symptoms often present in clusters (pain/depression), and treatment of all symptoms are important to often achieve relief of any symptom.

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