Table 3.
Summary of Registered Clinical Trials Exploring Stellate Ganglion Block for Psychiatric Disorders.
| NCT04302181 33 | NCT04582396 30 | NCT04727229 31 | DRKS00015817 32 | |
|---|---|---|---|---|
| Number of participants (projected) | 12 | 15 | 10 | 40 |
| Inclusion age | 18 to 65 | 18 to 85 | 18 to 65 | 18 to 50 |
| Inclusion sex/gender | All | All | All | All |
| Psychiatric disorder(s) | PTSD | PTSD (following cardiac arrest) | MDD | PTSD, BPD |
| Study type and design | Clinical trial, open-label design, single-group assignment | RCT, quadruple masking, parallel assignment | RCT, double masking, parallel assignment | RCT, no masking, parallel assignment |
| Comparison type | None | Experimental (SGB and psychoeducation) versus placebo (saline injection and psychoeducation) | Experimental (SGB) versus placebo injection (saline) | Experimental (SGB and dialectical behavior therapy) versus control (dialectical behavior therapy only) |
| SGB procedure | 1 treatment 6.5 mL ropivacaine 0.5% Laterality not reported Imaging technique not reported |
1 treatment 7 to 8 mL ropivacaine 0.5% Laterality not reported Imaging technique not reported |
1 treatment Unreported dose of bupivacaine 0.5% Laterality not reported Imaging technique not reported |
8 treatments; 2 per wk 3 mL ropivacaine 1% Bilateral Ultrasound guided |
| Additional treatments | Massed PE for 10 90-min sessions along with out of session treatment assignments for the majority of the day | Psychoeducation | None | Dialectical behavior therapy |
| Outcomes | Treatment efficacy (CAPS, PCL, PHQ-9, Brief Inventory of Psychosocial Functioning, GAD-7, PTCI) | Feasibility Treatment efficacy (PCL) Proportion of patients with clinically significant symptoms of cardiac anxiety, GAD and depression, moderate-high levels of physical activity, reduced sleep duration |
Feasibility, Recruitment, Acceptability, Safety Treatment efficacy (MADRS) |
Treatment efficacy (DSS-4, CGI, BDI, BSL-23, STAI-S, PCL-5, FDS, SCL-90-R, POSAS) |
Abbreviations: BPD, borderline personality disorder; BDI, Beck Depression Inventory; BSL, Borderline Symptom List; CAPS, Clinically Administered Posttraumatic Stress Disorder Scale; CGI, Clinical Global Impression Scale; DRKS, Deutsches Register Klinischer Studien (German Clinical Trials Register); FDS, Fragebogen fur dissoziative Symptome (questionnaire for dissociative symptoms); GAD, Generalized Anxiety Disorder; MADRS, Montgomery-Asberg Depression Rating Scale; MDD, major depressive disorder; NCT, National Clinical Trial number; PCL, posttraumatic stress disorder checklist; PE, prolonged exposure; PHQ-9, Patient Health Questionnaire - 9; POSAS, Patient and Observer Scar Assessment Scale; PTCI, Posttraumatic Cognitions Inventory; PTSD, posttraumatic stress disorder; RCT, randomized clinical trial; SCL-90-R, Symptom Checklist 90-R; SGB, stellate ganglion block; STAI-S, State-Trait-Anxiety Inventory-S;