Clinical Research Office

The Office of Psychiatric Clinical Research is designed to support psychiatric research in the clinical setting here at the Department of Psychiatry and Behavioral Neurobiology.

Our research division offers several cutting edge resources for Phase II, III and IV studies.  The coordination of our clinical trials is of the highest quality.  We are supported by experienced investigators and staff dedicated to academic excellence and quality patient care.  We have a full-time clinical research staff with regulatory and administrative services and assistance in designing clinical studies and providing referrals for statistical analysis.  We provide investigator training in psychiatric rating scales and standardized diagnostic instruments and education in patient recruitment.  We have a quality assurance program and facilities for drug storage, physical exams, EKG’s, interviewing, venipuncture and specimen processing. 

Currently Recruiting and Enrolling Trials

Mood Disorders

• "RECOVER: A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression"
  Principal Investigator: Matthew Macaluso, DO
• “Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)”
  Principal Investigator: Matthew Macaluso, D.O.
• “A Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy and Safety of Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder in Adults”
  Principal Investigator: Matthew Macaluso, D.O.
• “A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients with Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment”
  Principal Investigator: Matthew Macaluso, D.O.
• “Rapid Reversal of Suicidal Depression: Comparative Effectiveness of ECT vs. Ketamine Over the Lifespan”
  Principal Investigator: Matthew Macaluso, D.O.
• “A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEWMDD-2)”
  Principal Investigator: Matthew Macaluso, D.O.
• “A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression”
  Principal Investigator: Matthew Macaluso, D.O.
• “A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior”
  Principal Investigator: Matthew Macaluso, D.O.
• "Neuromodulation of Sleep and Mood: A Multimodal Biomarker Study of Non-Invasive Vagal Nerve Stimulation (MOSAIC-VNS)"
  Principal Investigator: Matthew Macaluso, D.O.

Not Currently Enrolling

• "A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression"
  Principal Investigator: Matthew Macaluso, DO
• "Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type"
  Principal Investigator: Matthew Macaluso, DO
• "A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression"
  Principal Investigator: Matthew Macaluso, DO
• "MicroRNA Correlates of Childhood Maltreatment and Suicidality"
  Principal Investigator: Yogesh Dwivedi, PhD
• "A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial with a quetiapine arm to evaluate the efficacy, tolerability and safety of oral BI 1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants."
  Principal Investigator: Matthew Macaluso, MD
• "Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent"
  Principal Investigators: Richard Shelton, MD and Matthew Macaluso, DO
• "A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder."
  Principal Investigator: Richard Shelton, MD
• "Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders with Treatment Resistant Depression (ASCERTAIN-TRD)"
  Principal Investigators: Richard Shelton, MD and Matthew Macaluso, DO
• “Plasma Exosomal MicroRNAs as Promising Noval Biomarkers for Suicidality and Treatment Outcome"
  Principal Investigator: Yogesh Dwivedi, PhD, Richard Shelton, MD
• "A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Fixed-doxe Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipolar I Depression"
  Principal Investigator: Richard Shelton, MD
• "A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder"
  Principal Investigator: Richard Shelton, MD
• “A Randomized Multicenter, Crossover Study to Assess the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Subjects With Major Depressive Disorder"
  Principal Investigator: Richard Shelton, MD
• “Do Micro RNAs Link Diabetes with Depression and Suicide?”
  Principal Investigator: Richard Shelton, MD, Yogesh Dwivedi, Ph. D.
• "A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus on Oral Antidepressant in Adult Subjects with treatment-resistant Depression"
  Principal Investigator: Richard Shelton, MD
• “A Randomized, Double-blind, Multicenter, Active-controlled Study of Intranasal Esketamine Plus and Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression"
  Principal Investigator: Richard Shelton, MD
• "A Prospective, Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment"
  Principal Investigator: Richard Shelton, MD
• "The Role of Epigenetic Regulation of Micro RNAs on Transgenerational of Early Life Stress Effects"
  Principal Investigator: Richard Shelton, MD, Yogesh Dwivedi, PhD
• "ALK5461-208: A Phase 3 Multicenter Study of the Long-term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorders in Adults who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)"
  Principal Investigator: Richard Shelton, MD
• "Phase 2, Open Label Extension for Subjects with Inadequate/Partial Response to Antidepressants during the Current Episode of Major Depressive Disorder Previously Treated with GLYX13 (Extension of GLYX13-C-202, NCT0184163)"
  Principal Investigator: Richard Shelton, MD
• "Cognitive Interviews of the Suicide Ideation and Behavior Assessment Tool (SIBAT) with Adolescent Subjects with a History of Suicidal Thinking"
  Principal Investigator: Richard Shelton, MD
• "Cognitive Interview of the Suicide ideation and Behavior Assessment Tool (SIBAT) with Clinicians"
  Principal Investigator: Richard Shelton, MD
• "Oxidative Stress Mechanisms in Mood Disorders"
  Principal Investigator: Richard Shelton, MD
• "Early life origins of obesity: the relationships between early life stress and abdominal obesity in depressed patients"
  Principal Investigator: Li Li, MD, PhD
• Characterize Cardiometabolic Risks in Adolescents: Impact of Early Life Stress
  Principal Investigator: Li Li, MD, PhD
• Chronic Inflammation in Patients with Opioid Use Disorder
  Principal Investigator: Li Li, MD, PhD
• "Psychiatric Biological Samples Repository"
  Principal Investigator: Richard Shelton, MD

Healthy Volunteers Needed

We have studies that require Healthy Volunteers. Please contact us to find out what we have available.  

Contact

UAB Department of Psychiatry
Office of Psychiatric Clinical Research
1720 7th Avenue South
Sparks Building, 10th Floor
Birmingham, AL 35294-0017

Telephone:  (205) 934-2484

Email: psychresearch@uab.edu