Clinical Research Studies

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

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

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

Upcoming Studies

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 8 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.

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (P-TRD)

 

A randomized study to determine the optimal therapeutic dose of Psilocybin in Treatment Resistant Depression (TRD). The main purpose of this study is to test how well psilocybin works to lessen depressive symptoms.

We will do this by comparing the effect of a single dose of 10mg or 25mg of psilocybin with a lower dose of 1mg. Your depressive symptoms will be measured by a change in your score for a questionnaire that looks at your depressive symptoms.  

Psilocybin is a controlled drug and a chemical compound found in some species of mushrooms. Recent studies have suggested that psilocybin may help in treating depression and we wish to investigate this further. Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood. Current regulations do not allow psilocybin to be prescribed in the United States for treating depression, although it has been approved for use in this research study. 

This research study is expected to take approximately 2 years to complete.  We will ask you to make at least 12 study visits to Stanford University. On the day of the psilocybin session, you will arrive at the clinical center between 8am and 9am. You may require additional visits if you need a longer time to stop your antidepressant medication.


Other Clinical Trial Opportunities for Depression at Stanford Medicine

Brain Stimulation Lab

Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study

This research study is looking for ninety-five people with depression to enroll at Stanford University.   

A new treatment for depression involves stimulating the brain with an electromagnet placed on the scalp that rapidly turns on and off. This treatment is called transcranial magnetic stimulation. As the magnet rapidly turns on and off, the electrical currents in the brain tend to synchronize with the magnet. Brief treatments with this appear to help patients with depression.

 This study is looking for participants that have depression with a history of being unresponsive to at least one medication, that might respond to this new treatment. This new treatment is looking at a new way of using transcranial magnetic stimulation to treat depression and is called theta burst stimulation. It involves using a shorter period of stimulation for each treatment, which might benefit patients. We hope to learn if this shorter type of transcranial magnetic stimulation is effective in treating depression. 

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/stanford_atbs_study

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

 Claudia Tischler          650-498-8535    ctischler@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:

Romina Nejad     650-497-3933    rnejad@stanford.edu

 

Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia

NIH/NCCIH Grant # 1R33AT009305-01

ClinicalTrials.gov ID: NCT02969707

We will be using function neuroimaging (fMRI) to understand the brain systems affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of rTMS-augmentation on hypnotic analgesia networks. We hope to demonstrate that a combination of these psychological and neuromodulatory treatments will be more effective than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the efficacy of hypnotic analgesia and hopefully creating a new treatment modality for individuals suffering from pain syndromes such as fibromyalgia pain. 

If you have been diagnosed with fibromyalgia and are interested in participating, please fill out our quick survey to see if you qualify (only takes ~2 minutes).

https://is.gd/brainstimulationstudy

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

650-736-2233 or brainstimulationstudy@stanford.edu

 


Studies not actively recruiting

Current Studies  

  • 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)