This Phase III, placebo-controlled, randomised, quadruple-blind trial (n=220) will assess the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analogue, as an adjunctive treatment for major depressive disorder (MDD). Participants will receive either 16 mg of CYB003 or a placebo in two dosing sessions, approximately three weeks apart, while continuing their current antidepressant medication and receiving psychological support.
Status: Recruiting
Start date: 2024-11-15
Phase III
Blinded
220 participants
Interventional
This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy (MDMA-AT) (80 mg for the first session, 120 mg for the second and third, with an optional supplemental dose of 50% of the initial dose) for participants diagnosed with pathological narcissism.
Status: Recruiting
Start date: 2024-08-27
Phase I
Open
12 participants
Interventional
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) (EXTEND)
This open-label, phase III long-term extension trial (n=220) aims to assess the safety and long-term efficacy of CYB003 in participants with major depressive disorder (MDD). Participants will receive up to three doses of 16 mg of CYB003, administered in medicine sessions approximately three weeks apart.
Status: Not yet recruiting
Start date: 2025-02-23
Phase III
Open
220 participants
Interventional
This double-blind, placebo-controlled trial (n=45) will assess the safety and efficacy of two doses of intravenous (2R,6R)-Hydroxynorketamine (RR-HNK) in adults with obsessive-compulsive disorder (OCD). Participants will receive either 17.5mg/70kg or 35mg/70kg of RR-HNK, or a placebo, via a single infusion.
Status: Not yet recruiting
Start date: 2024-12-01
Phase I
Blinded
45 participants
Interventional
This observational, case-crossover trial (n=15) will evaluate the subjective experience of a novel virtual reality programme (VRP), DeepDream, in comparison to a standard dose of psychedelics.
Status: Not yet recruiting
Start date: 2025-02-15
Not Applicable
Open
15 participants
Observational
This randomised, quadruple-blind, placebo-controlled trial (n=60) will investigate the role of the 5-HT2A receptor in mediating the subjective and antidepressant effects of psilocybin in individuals with Major Depressive Disorder (MDD). Participants will receive a single dose of psilocybin (25mg) combined with either pimavanserin (34mg; atypical antipsychotic) or a placebo.
Status: Recruiting
Start date: 2025-02-01
Phase II
Blinded
60 participants
Interventional
This open-label, early Phase I trial (n=10) will assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression.
Status: Not yet recruiting
Start date: 2025-01-01
Phase I
Open
10 participants
Interventional
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 post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI)-associated headaches.
Status: Not yet recruiting
Start date: 2025-02-15
Phase II
Blinded
175 participants
Interventional
This open-label observational trial (n=20) will investigate the effects of intravenous ketamine on treatment-resistant bipolar depression, with an interventional component of functional magnetic resonance imaging (fMRI).
Status: Recruiting
Start date: 2024-11-12
Phase II
Open
20 participants
Observational
This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.
Status: Not yet recruiting
Start date: 2024-10-30
Phase I
Blinded
40 participants
Interventional
This interventional trial (n=20) will assess the feasibility of combining Acceptance and Commitment Therapy (ACT) with ketamine intervention in patients with alcohol use disorder (AUD) and comorbid treatment-resistant depression (TRD).
Status: Not yet recruiting
Start date: 2025-05-01
Not Applicable
Open
20 participants
Interventional
This single-site, randomised, controlled clinical trial (n=70) will compare ketamine-assisted psychotherapy (KAP) to standard medical ketamine administration (KET) for the treatment of major depressive disorder (MDD), using doses ranging from 21 mg/70 kg to 70 mg/70 kg.
Status: Recruiting
Start date: 2025-01-01
Phase II
Blinded
70 participants
Interventional
This open-label, randomised trial (n=24) will examine the feasibility of combining meditation with psilocybin microdosing in healthy adults.
Status: Not yet recruiting
Start date: 2024-10-01
Not Applicable
Open
24 participants
Interventional
This observational pilot study (n=10) will investigate the reactivity of salivary oxytocin during a single dose of lysergic acid diethylamide (LSD) as part of psychedelic-assisted psychotherapy (PAP) for anxiety disorders or depression.
Status: Recruiting
Start date: 2024-08-05
Not Applicable
Open
10 participants
Observational
This interventional trial (n=40) will evaluate the safety and effectiveness of hormone replacement therapy (HRT), magnetic resonance therapy (MeRT), ibogaine, and 5-MeO-DMT in treating post-traumatic stress disorder (PTSD) and cognitive difficulties in Special Operations Forces veterans with a history of combat deployment and traumatic brain injury (TBI).
Status: Not yet recruiting
Start date: 2025-03-01
Phase II
Open
40 participants
Interventional
This randomised controlled feasibility trial (n=40) will evaluate a 21-day digital intervention for psychedelic preparation (DIPP) using either a meditation-based or music-based programme, followed by a supervised 25 mg psilocybin session at University College London.
Status: Recruiting
Start date: 2025-03-01
Phase I
Open
40 participants
Interventional
This open-label trial (n=10) will study the feasibility, safety, and preliminary effectiveness of psilocybin-assisted therapy (PAT/Psi-AT) in reducing burnout symptoms among physicians at the University of California, San Diego (UCSD). Participants will receive a single 25 mg dose of synthetic psilocybin alongside preparatory and integrative therapy.
Status: Not yet recruiting
Start date: 2025-04-01
Phase I
Open
10 participants
Interventional
This open-label Phase I trial (n=15) will investigate the effects of psilocybin (25mg) on brain function and cognitive control in healthy adults, using electroencephalogram (EEG) and transcranial magnetic stimulation (TMS).
Status: Not yet recruiting
Start date: 2025-03-01
Phase I
Open
15 participants
Interventional
This open-label, Phase I trial (n=15) will assess the safety and efficacy of psilocybin (25mg) alongside psychotherapy for treating demoralization syndrome in patients with advanced-stage cancer.
Status: Not yet recruiting
Start date: 2025-03-01
Phase I
Open
15 participants
Interventional
This randomised, quadruple-masked (participant, care provider, investigator, outcomes assessor), interventional Phase II trial (n=24) will study the effects of psilocybin (1mg or 25mg; PEX010) on brain mechanisms related to motivation, reward, and cognitive flexibility in individuals with opioid use disorder (OUD).
Status: Not yet recruiting
Start date: 2025-03-01
Phase II
Blinded
24 participants
Interventional
This randomised, triple-blind, placebo-controlled trial (n=40) will investigate the effects of psilocin (16mg oral; CYB003) on brain activity and connectivity in individuals with major depressive disorder (MDD) and moderate to severe anxiety.
Status: Not yet recruiting
Start date: 2025-03-01
Phase II
Blinded
40 participants
Interventional
This Phase II trial (n=20) will study the safety, tolerability, and effectiveness of low-dose psilocybin therapy combined with psychotherapy for managing chronic pain in cancer patients who require opioids. Participants will receive psilocybin twice weekly for four weeks (8 doses total) alongside preparatory and integration psychotherapy sessions.
Status: Not yet recruiting
Start date: 2025-03-03
Phase II
Open
20 participants
Interventional
This observational cohort study (n=128) will evaluate the sustained effectiveness of intravenous (IV) ketamine for suicidal ideation in adults experiencing a suicidal crisis due to major depressive disorder.
Status: Completed
Start date: 2023-12-01
Not Applicable
Open
128 participants
Observational
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.
Status: Not yet recruiting
Start date: 2025-06-01
Phase II
Blinded
200 participants
Interventional
This double-blind, placebo-controlled trial (n=1670) will assess the effect of low-dose esketamine on postoperative delirium in elderly high-risk patients undergoing major non-cardiac surgery. Participants will receive either esketamine (14mg/70kg loading dose, followed by 7mg/70kg/h infusion) or a placebo during surgery, with esketamine included in postoperative patient-controlled analgesia.
Status: Not yet recruiting
Start date: 2025-02-01
Not Applicable
Blinded
1670 participants
Interventional
This observational cohort study (n=30) will explore how veterans aged 65 and older enrolled in VA healthcare perceive ketamine-assisted psychotherapy (KAP) for depression and end-of-life distress.
Status: Recruiting
Start date: 2024-11-08
Not Applicable
Open
30 participants
Observational
This observational cohort study (n=200) will assess whether a speech-based machine learning algorithm can predict treatment response to psychiatric interventions, specifically repetitive transcranial magnetic stimulation (TMS) and Spravato (esketamine) nasal spray.
Status: Not yet recruiting
Start date: 2025-02-01
Not Applicable
Open
200 participants
Observational
This Phase I/II randomised, triple-blind, placebo-controlled trial (n=40) will investigate the safety, tolerability, and potential therapeutic effects of sublingual 5-MeO-DMT (6 mg, 9 mg, or 12 mg) in individuals with elevated symptoms of anxiety and depression. Participants will receive one dose per week for four weeks, with monitoring throughout the trial.
Status: Completed
Start date: 2024-10-21
Phase I
Blinded
40 participants
Interventional
This Phase I/II randomised, triple-blind, placebo-controlled trial (n=20) will study the effects of sublingual 5-MeO-DMT (6 mg, administered weekly for four weeks) on anxiety, depression, and cognitive function in individuals with mild to moderate Alzheimer's disease.
Status: Active, not recruiting
Start date: 2024-12-15
Phase I
Blinded
20 participants
Interventional
This open-label trial (n=50) will assess the safety and efficacy of psilocybin-assisted psychotherapy in patients with treatment-resistant major depressive disorder (TRD) in an Australian clinical setting. Participants will receive two doses of psilocybin (25mg each) alongside a structured programme of preparatory and integration psychotherapy sessions over approximately 16–18 weeks.
Status: Planned
Start date: 2024-11-20
Phase II
Open
50 participants
Interventional
Find Psychedelic Trials
Browse through all psychedelic trials that have been done or are ongoing. These trials, usually double-blind, placebo-controlled studies, are the core of psychedelic research. The outcome of these trials will determine the future of psychedelics as medicine.
The trials included in our database come from ClinicalTrials.Gov and from the various companies pursuing psychedelics as medicine. Most of the trials have been funded by universities, though companies and governments are currently starting to ramp up their involvement.
