SUMMARY  

• SPRAVATO has not been studied and is not indicated for the treatment of fibromyalgia.
• In a real‑world retrospective analysis of patients treated with IV ketamine or SPRAVATO for treatment‑resistant depression (N=62), the presence of comorbid chronic pain or fibromyalgia (n=7) was significantly associated with clinical response but not with remission (response: P=0.035; remission: P=0.098).¹ 

CLINICAL DATA

Singh et al (2023)¹ conducted a comparative observational study in a real-world setting

among adult patients with TRD (N=62) who had received up to 6 IV ketamine infusions

(0.5 mg/kg; n=47 [76%]) or up to 8 SPRAVATO doses (56 mg/84 mg; n=15 [24%]). The primary objective was to compare the effectiveness of the two treatment groups, measured by baselinetoendpoint change in the Quick Inventory of Depressive Symptomatology SelfReport (QIDSSR) score, rates of response (≥50% reduction in QIDSSR) and remission (QIDSSR score ≤5), and time to response and remission (defined as number of treatments). This study also aimed to evaluate the effect of comorbidities on treatment effectiveness.

Results

• Among the total study population, 58.1% (36/62) of patients achieved a clinical response and 38.7% (24/62) achieved remission.
• Of the 62 patients included in the study, 7 (11.3%) had comorbid chronic pain or fibromyalgia, and 3 of those received SPRAVATO.
• Within the comorbid chronic pain or fibromyalgia subgroup, all patients (7/7; 100%) attained a clinical response and five (5/7; 71.4%) patients achieved remission.
• Presence of chronic pain or fibromyalgia was significantly associated with clinical response (P=0.035) but not remission (P=0.098).

Limitations

• The study was small and nonrandomized. Comparative response and remission rates for IV ketamine versus SPRAVATO within the comorbid fibromyalgia or chronic pain subgroup were not reported, further limiting inferences about the effectiveness of SPRAVATO in this subgroup.
• Patient recruitment from a tertiary referral center with a higher proportion of severe TRD may introduce referral bias.
• QIDS-SR scores were not collected for all patients within 24 hours post infusion after each treatment.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT Drug databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 07 January 2026.