Clinical Research Studies

SPECIALIZING IN NOVEL AND INNOVATIVE RESEARCH APPROACHES FOR ALL TYPES OF CLINICAL DEPRESSION

***Due to current Covid-19 regulations, some studies are currently enrolling via televisits. We will be reviewing new applicants and enrolling when permitted. Please be aware that response times may be greater than usual during this time. ***

Recruiting Now

Augmentation versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders with Treatment Resistant Depression (ASCERTAIN-TRD)

If you are between the ages of 18 and 80, currently depressed and have a history of trying at least one antidepressant medication you may be eligible.

This study involves comparing three treatment arms:

1.  Adding Abilify® to current antidepressant medication

2.  Adding Repetitive Transcranial Magnetic Stimulation (rTMS) to current antidepressant medication, or

3.  Switching your current antidepressant medication to Effexor® Extended Release, or to Cymbalta®

These three treatments are approved by the FDA to treat TRD.  If enrolled, this study involves 9 visits over ~12 weeks.

Participants will receive compensation for their time.

If you are currently taking an antidepressant medication that is only partially helping your depression, please fill out our online survey, call (650) 723-8330 or email depressionresearch@med.stanford.edu.

For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT02977299

Opiate Suicide Study in Patients with Major Depression

We are doing this study to determine if suicidal thoughts are lessened after an infusion of ketamine followed by 4 weeks of a medication called buprenorphine. Participants for this research will be currently experiencing depression and will have not responded to treatment with antidepressants or have an intolerance to these types of medicines. Recent studies have shown a single infusion of ketamine to reduce suicidal ideation within 24 hours and to last for at least one week.  We would like to determine if a single infusion of ketamine followed by 4 weeks of low dose burprenorphine produces longer lasting anti-suicidal effects than does ketamine followed by placebo.

This research study is expected to take approximately 2 years to complete with at least 6 weeks of active participation by each participant.  During this time, participants will make 10 study visits to Stanford University, including an 8-hour infusion visit.

Under the close supervision and monitoring by the study clinicians, eligible subjects will receive a single infusion of ketamine 0.5mg/kg followed by oral buprenorphine or placebo for 4 weeks.

This research study will use either Buprenorphine or a placebo, containing no drug, to study if the benefits experienced from Ketamine can be improved or last longer when buprenorphine is taken for 4 weeks.

To find out if this study is a good fit for you, please fill out our online survey, call (650) 723-8330 or email depressionresearch@med.stanford.edu.

For further details, please see the following link: https://clinicaltrials.gov/ct2/show/NCT04116528

Other Clinical Trial Opportunities for Depression at Stanford Medicine

Brain Stimulation Lab

Neuroimaging Biomarkers for Predicting rTMS Response in OCD

 

We are doing this research study to find if a new form of Repetitive transcranial magnetic stimulation (rTMS) is an effective in treating OCD. So far, at least two stimulation targets have consistent evidence of efficacy in OCD: the dorsomedial prefrontal cortex (DMPFC) and the orbitofrontal cortex (OFC). Patients often show a strong response to one target but not the other. It is not well understood why some patients respond, while others do not. So far, there are no biomarkers for predicting treatment response, identifying the optimal neuroanatomical target, or choosing between treatments.

 

This study evaluates an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for treatment-resistant Obsessive Compulsive Disorder (OCD). In a randomized fashion, half the participants will receive accelerated theta-burst stimulation at the dorsomedial prefrontal cortex (DMPFC), while half will receive accelerated theta-burst stimulation at the right orbitofrontal (rOFC) site.

This study has begun recruiting phase, please follow link below to confirm your interest in the study and complete screening questionnaires. 

 

 

If you would prefer to speak to a member of our study team, please contact us at:

Nick Bassano   650-721-8377 nbassano@stanford.edu

For further information on the clinical trial, click here

 

Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression: A Biomarker Study

We are doing this research study to find out if a new form of repetitive transcranial magnetic stimulation (rTMS) is effective in treating treatment-resistant bipolar depression. rTMS is approved by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in adults with depression that have not benefited from medication. This FDA-approved treatment involves stimulating the left frontal area of the head with an electromagnet that produces a magnetic field delivered in short bursts. These bursts are focused on an area of the brain that is thought to be involved in causing depression. As the magnet rapidly turns on and off, the electrical currents in the brain tend to synchronize with the magnet. TMS has been shown to help some patients with depression.

In this study, we are looking at a new way of using intermittent TBS to treat treatment-resistant bipolar depression.  The name of this new procedure is “accelerated intermittent theta-burst stimulation (aiTBS)”.  aiTBS involves using shorter periods of stimulation over multiple treatments received each day for five days.  We hope to learn if this shorter type of TMS is effective in treating bipolar depression. This open-label pilot study will be conducted with 30 patients who will receive active aiTBS treatment.

If you have been diagnosed with treatment-resistant depression and are interested in participating, please fill out our survey to see if you qualify. This is a multi-step screening process.

https://is.gd/bipolar_screening_atbs

If you would prefer to speak to a member of our study team, please contact us at:

Nick Bassano   650-721-8377 nbassano@stanford.edu

For further information on the clinical trial, click here

 


Studies not actively recruiting

Current Studies  

  • The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (P-TRD)
  • Identifying Biological Markers for Severe Depression
  • Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
  • A Prospective, Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment (Schatzberg)
  • A Pilot study of Self-Defense Training in Women with Trauma (Keller)

 

Past Research Studies

  • Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD) (N. Williams)
  • Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD) (C. DeBattista)
  • A Long-term Follow-Up Study for the Evaluation of Patients who have a Deep Brain Stimulation System for the Adjunctive Treatment of Major Depressive Disorder (C. DeBattista)
  • A 12-Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open-Label 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering from a Major Depressive Disorder (MDD) and Having Had – Within the Current Episode - an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic (C. DeBattista)
  • Radiosurgical Neuromodulation for Refractory Depression (H.B. Solvason)
  • A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants. (C. DeBattista)
  • A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (C. DeBattista)
  • A Randomized, Parallel-group, Sham-controlled, Multisite Study to Evaluate the Efficacy and Safety of the Neurostar® Transcranial Magnetic Stimulation Clinical Research System in Patients with Major Depressive Disorder (H.B. Solvason)
  • An Open Label, Multisite Study to Evaluate the Efficacy and Safety of the Neurostar® Transcranial Magnetic Stimulation Clinical Research System in Patients with Major Depressive Disorder (H.B. Solvason)
  • A Twelve Month, Open-Label, Safety Trial of Fliberanserin 50 Milligrams to 100 Milligrams Daily in Women with Hypoactive Sexual Desire Disorder (C. DeBattista)
  • A Twenty Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Flibanserin 25 Milligrams Twice Daily and 50 Milligrams Once Daily and Twice Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in North America. (C. DeBattista)
  • Ropinerole CR as an Adjunctive Agent in the Treatment of Major Depression (C. DeBattista)
  • A Multicenter, Randomized, Blinded, Controlled, Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy in Subjects with Depression Treatment Failure. (C. DeBattista)
  • Quantitative Characterization of Insulin Resistance in Patients with Bipolar Disorder Treated with Atypical Antipsychotic Medication: Effect of Treatment with an Oral Hypoglycemic Agent (H.B. Solvason)
  • A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects with Major Depressive Disorder (C. DeBattista)
  • A Double-Blind, Placebo-Controlled Study of Mifepristone in Patients with Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT) (H.B. Solvason)
  • Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits following Unilateral ECT for the Treatment of a Severe Major Depressive Episode (H.B. Solvason)
  • An 8-week, randomized, double blind, fixed dosage, placebo-controlled, parallel group, multi-center study of the efficacy, safety and tolerability of agomelatine 25 mg and 50 mg in the treatment of Major Depressive Disorder (MDD) followed by a 52 week, open-label extension (C. DeBattista)
  • International Study to Predict Optimised Treatment in Depression. (C. DeBattista)
  • Neurobiological and Cognitive Comparison of Psychotic Major Depression, Schizoaffective Disorder, Schizophrenia, and Non Psychotic Major Depression (J. Keller)