Clinical TrialParallelKetaminePlaceboCompleted

Oral Ketamine vs Diclofenac for Mild-to-Moderate Depression in Chronic Headache Patients: A Double-Blind RCT (IRCT201508201556N80, Imam Hospital Tehran)

Six-week, randomised, double-blind, parallel-group outpatient trial (IRCT201508201556N80; Imam Hospital, Tehran University of Medical Sciences, Iran; January–December 2015). Participants: 46 adults aged 20–55 with chronic persistent headache (≥6 months requiring analgesia) and mild-to-moderate MDD (DSM-IV-TR, HDRS-17 score <19). Arms: (1) oral ketamine 50 mg three times daily (150 mg/day); (2) oral diclofenac 50 mg three times daily. Capsules were indistinguishable. Primary outcome: change in HDRS from baseline to weeks 3 and 6. Secondary: HADS depression subscale, response/remission rates, pain VAS, adverse events. Randomisation by computer-generated sequence (1:1, blocks of 4); concealed in sequentially numbered sealed envelopes; participants, investigators and raters blinded.

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Target Enrollment
46 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

Ketamine

experimental

Oral ketamine 50 mg capsules, three times daily for 6 weeks

Interventions

  • Ketamine50 mg
    via Oral• three times daily• 126 doses total

    Fixed daily dosage of 150 mg

Diclofenac

active comparator

Oral diclofenac 50 mg capsules, three times daily for 6 weeks

Interventions

  • Placebo50 mg
    via Oral• three times daily• 126 doses total

    Fixed daily dosage of 150 mg

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment46 participants
  • Timeline
    Start: 2015-01-01
    End: 2015-12-31
  • Compounds
    KetaminePlacebo

Related Publications

PaywallindividualPrimary

Efficacy and safety of oral ketamine versus diclofenac to alleviate mild to moderate depression in chronic pain patients: A double-blind, randomized, controlled trial

This double-blind study (n=40) compared the efficacy and safety of oral ketamine and diclofenac as treatments of mild to moderate depression over a 6-week treatment period and found that ketamine resulted in significant reductions of depression scores above those achieved by diclofenac.

Published
Journal
Journal of Affective Disorders
Authors
Jafarinia, M., Afarideh, M., Tafakhori, A., Arbabi, M., Ghajar, A., Noorbala, A. A., Saravi, M. A., Agah, E., Akhondzadeh, S.

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