Clinical trials: Treatment-resistant Depression
Bipolar Depression, Bipolar Disorder
Theta-Burst Stimulation for Bipolar Depression
The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder.
- Conditions
- Bipolar Depression, Bipolar Disorder, Treatment- Resistant Bipolar Disorder, Type 2 Bipolar Disorder
- Trial name
- TRIBE (NCT06370988)
- Testing
- iTBS Stimulation
- Where
- 2 sites in Canada
- Volunteers
- 124 people
- Sponsor
- Centre for Addiction and Mental Health
Major Depressive Disorder, Suicide
i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years).
- Conditions
- Major Depressive Disorder, Suicide, Treatment Resistant Depression
- Trial name
- Ket-CBT (NCT06480500)
- Testing
- Ketamine hydrochloride, i-CBT (Internet-based Cognitive Behavioural Therapy), Midazolam Hydrochloride
- Where
- Canada
- Volunteers
- 76 people
- Sponsor
- University Health Network, Toronto
Suicide, Depressive Disorder, Treatment-Resistant
Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression
Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective.
- Conditions
- Suicide, Depressive Disorder, Treatment-Resistant, Ketamine, Molecular Mechanisms of Pharmacological Action
- Trial name
- NCT06511908
- Testing
- (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Mental Health (NIMH)
Depression, Suicide Risk
Long-term Observation of Participants With Mood Disorders
Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program.
- Trial name
- NCT04877977
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Mental Health (NIMH)
Behavioral Symptoms, Suicide
Natural History of Depression, Bipolar Disorder and Suicide Risk
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments.
- Conditions
- Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents
- Trial name
- NCT06462196
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Institute of Mental Health (NIMH)
Major Depression
iTBS Versus Standard 10 Hz rTMS for Treatment-Resistant Depression (TRD)
This randomised, parallel-group, non-inferiority trial compared intermittent theta burst stimulation (iTBS, 3-minute sessions) with standard 10 Hz repetitive transcranial magnetic stimulation (rTMS, 37-minute sessions) applied to…
- Trial name
- iTBS-TRD (NCT07852065)
- Testing
- iTBS, rTMS
- Where
- Egypt
- Volunteers
- 182 people
- Sponsor
- Kafrelsheikh University
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are…
- Trial name
- NCT06773949
- Testing
- Theta burst stimulation
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- The Royal Ottawa Mental Health Centre
Treatment Resistant Depression (TRD)
Dehydroepiandrosterone (DHEA) as Augmentation of Standard Antidepressants in Treatment-resistant Depression.
Major depressive disorder (MDD) is a major contributor to impaired health worldwide. Initial antidepressant treatment of MDD does not lead to response in up to 50 % of patients.
- Trial name
- DARE (NCT07843927)
- Testing
- Dehydroepiandrosterone (DHEA)
- Where
- 9 sites in Germany
- Volunteers
- 320 people
- Sponsor
- Charite University, Berlin, Germany
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
The goal of this clinical trial is to learn if combining a ketogenic diet with a personalized, accelerated brain stimulation treatment (iTBS) works better than iTBS with a standard healthy diet to reduce depression symptoms in…
- Trial name
- ALIGN (NCT07376018)
- Testing
- Accelerated Intermittent Theta Burst Stimulation (iTBS), Ketogenic Diet, Canadian Food Guide-Aligned Diet
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Sunnybrook Health Sciences Centre
Treatment Resistant Depression (TRD), Chronic Pain
Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression
The goal of this clinical trial is to understand the effect of ketamine on the brain in people with treatment-resistant depression (TRD).
- Trial name
- NCT07247006
- Testing
- Ketamine hydrochloride injection
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Rochester
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Biomarker-Guided Antidepressant Selection
Depression is one of the leading causes of disability worldwide. Common treatments like antidepressant medications and talk therapy work well for some people, but many others do not improve, even after trying multiple treatments.
- Conditions
- Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD), rTMS, Ketamine
- Trial name
- BioSelect (NCT07680140)
- Testing
- TMS, Ketamine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Weill Medical College of Cornell University
Major Depressive Disorder, Treatment Resistant Depression
DBS for TRD With the Medtronic Percept PC
Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant.
- Trial name
- NCT05773755
- Testing
- Medtronic Percept PC DBS system
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Helen Mayberg, MD
Treatment Resistant Depression (TRD), Major Depressive Disorder (MDD)
Home-Based Randomized Trial of Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression
This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision.
- Trial name
- NCT07834762
- Testing
- Spaced Transcranial Direct Current Stimulation (tDCS)
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of California, San Diego
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.
- Trial name
- PSILOTRAZ (NCT07210112)
- Testing
- Psilocybin 25 mg per os, Trazodone 5mg, Trazodone 30 mg
- Where
- France
- Volunteers
- 112 people
- Sponsor
- Centre Hospitalier St Anne
Schizophrenia, Treatment Resistant Depression (TRD)
Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
The disruption of immune system is a key candidate in the pathogenesis of psychiatric disorders, especially those resistant to traditional treatments.
- Conditions
- Schizophrenia, Treatment Resistant Depression (TRD), Bipolar Disorder (BD), Catatonia
- Trial name
- BIO-INM (NCT07741981)
- Testing
- Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales
- Where
- France
- Volunteers
- 700 people
- Sponsor
- Centre Hospitalier St Anne
Treatment Resistant Depression
Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)
The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary…
- Trial name
- NCT06236711
- Testing
- tDCS
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Major Depressive Disorder (MDD)
Imaging- vs. Scalp-Targeted Accelerated TMS for Depression: The Number Needed to Scan Trial
Transcranial magnetic stimulation(TMS) is a non-invasive form of brain stimulation that is cleared by the United States Food and Drug Administration (FDA) for depression.
- Trial name
- NNS (NCT07043738)
- Testing
- Transcranial Magnetic Stimulation
- Volunteers
- 160 people
- Sponsor
- Brigham and Women's Hospital
Treatment-Resistant Depression
NRX-101 Expanded Access
The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have treatment-resistant depression and who are unable to participate in, or do not have access to, the ongoing NRX-101 clinical…
- Trial name
- NRX-101 EAP (NCT05779267)
- Testing
- NRX-101
- Where
- United States
- Sponsor
- NeuroRx, Inc.
Depression, Treatment Resistant Depression
Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression
SHAKTI (from the Sanskrit word for "power") is a 5-year natural history, longitudinal, prospective study of a cohort of 6,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and…
- Conditions
- Depression, Treatment Resistant Depression, Mood Disorders, Bipolar Disorder
- Trial name
- SHAKTI (NCT06002204)
- Testing
- Observational Study
- Where
- United States
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Treatment Resistant Depression (TRD)
Ketamine Treatment for Treatment-Resistant Depression - the Role of Framing
Ketamine is a medicine used in psychiatry for treatment-resistant depression. This study compares two ways of framing ketamine treatment: a psychedelic framing and a biomedical framing.
- Trial name
- KetSet (NCT07824973)
- Testing
- Psychedelic framing, Biomedical framing
- Where
- Sweden
- Volunteers
- 120 people
- Sponsor
- Valdemar Landgren