Placebo for PTSD

1 paper and 23 clinical trials exploring placebo as a treatment for ptsd.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

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Indication354 million people suffering from PTSD globally.

PTSD

Posttraumatic stress disorder (PTSD) is a significant mental health challenge affecting over 354 million individuals globally. Psychedelics, particularly MDMA and psilocybin, are emerging as promising therapeutic options, offering new avenues for treatment through innovative psychotherapeutic interventions.

Full PTSD profile

Academic Research

1 paper

Paywallindividual

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

This multi-site, randomised, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population.

Published: September 14, 2023
Journal: Nature Medicine
Authors: Balliett, B., Bogenschutz, M. P., de Boer, A., Doblin, R., Gelfand, Y., Hamilton, S., Harrison, C., Kleiman, S., Mitchell, J., Mithoefer, A. T., Nicholas, C. R., Ot’alora G, M., Paleos, C., Parker-Guilbert, K., Quevedo, S., Shannon, S., Tzarfaty, K., van der Kolk, B., Yazar-Klosinski, B.

Clinical Trials

23 trials

Not yet recruitingPhase II

Department of Defense PTSD Adaptive Platform Trial – Intervention D – SLS-002

This Phase II randomised, quadruple-blind, placebo-controlled trial (n=200) will assess the safety and efficacy of intranasal SLS-002 (ketamine, 78mg) for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.

Started: June 1, 2025
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT06816433

RecruitingPhase II

Psilocybin with Psychological Support (Psi-PS) for Military Veterans and First Responders with Co-occurring PTSD & Alcohol Use Disorder (AUD) (Psi-PS)

This Phase II, double-blind, placebo-controlled trial (n=40) will investigate the safety, effectiveness, and lasting effects of psilocybin (25mg) combined with psychological support (Psi-PS) in military veterans and first responders with both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD).

Started: March 1, 2025
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT06853912

RecruitingPhase II

Ketamine, SGB and Combination Treatment for TBI

This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating PTSD and TBI-associated headache.

Started: February 15, 2025
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT06608277

RecruitingPhase IV

The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD

Prospective randomised pilot trial (n=30) comparing outpatient IV ketamine (0.5 mg/kg/hr) vs ketamine+magnesium vs magnesium control in military patients with chronic neuropathic pain; PTSD outcomes are secondary.

Started: May 1, 2024
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: NCT06414356

Not yet recruitingPhase II

Ketamine Treatment for PTSD and MDD in TBI

Randomised, quadruple-blind, parallel Phase II trial (n=40) comparing IV ketamine 0.5 mg/kg vs midazolam 0.045 mg/kg twice weekly for 3 weeks in Veterans with mild–moderate TBI and comorbid PTSD and MDD to evaluate efficacy and safety.

Started: March 1, 2024
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT06228391

Unknown statusPhase II

Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD

This randomized, double-blind, placebo-controlled study (n=160) aims to evaluate the safety, tolerability, and efficacy of Psilocybin-Assisted Psychotherapy (APEX-002-A02) in treating severe depression among adults with Post-Traumatic Stress Disorder (PTSD).

Started: December 15, 2023
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT06141876

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