Psychiatry & Mental Health clinical trial failures

Phase I Pain trial by University of Utah. Stop reason: OTHER/UNKNOWN.

Study is paused while preparing for implementation at IND Sponsor's new institution

Phase II Panic Disorder trial by HB BioTech, LLC. Stop reason: OPERATIONAL.

Recruitment paused for Data Monitoring Committee (DMC) to review interim analysis data.

Phase IV Posttraumatic Stress Disorder trial by VA Office of Research and Development. Stop reason: OPERATIONAL.

difficulty meeting recruitment goals

Phase II Anxiety trial by University of Florida. Stop reason: OPERATIONAL.

Study terminated early secondary to limited staffing resources

Unknown Dental Anxiety trial by University Hospital, Strasbourg, France. Stop reason: OTHER/UNKNOWN.

inclusion challenges

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Early study termination due to insufficient efficacy.

Phase IV Depression, Unipolar trial by New York State Psychiatric Institute. Stop reason: OTHER/UNKNOWN.

The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Phase II Major Depressive Disorder With Suicidal Ideation With Intent trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Terminated by Novartis

Phase II Major Depressive Disorder trial by University of Chicago. Stop reason: OTHER/UNKNOWN.

PI has left the university

Phase I Methamphetamine Use Disorder trial by University of Wisconsin, Madison. Stop reason: OPERATIONAL.

due to sponsor financial constraints

Phase IV Substance Use Disorders trial by Montefiore Medical Center. Stop reason: OPERATIONAL.

Difficulty recruiting and enrolling participants

Phase III ADHD trial by Cingulate Therapeutics. Stop reason: OTHER/UNKNOWN.

Continuation of the study is not required for NDA submission via the 505(b)(2) pathway

Phase II Treatment Resistant Depression trial by Merck Sharp & Dohme LLC. Stop reason: SAFETY.

Voluntarily terminated due to benefit/risk assessment

Phase II Anxiety trial by University of Calgary. Stop reason: OTHER/UNKNOWN.

No research capacity to support the project at this time.

Phase I Schizophrenia trial by New York State Psychiatric Institute. Stop reason: OPERATIONAL.

U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. NKI site is open for enrollment.

Phase II Non-segmental Vitiligo trial by Vyne Therapeutics Inc.. Stop reason: OPERATIONAL.

Business Decision

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: OPERATIONAL.

The study was Early Terminated as per Sponsor's decision (communicated to sites on 06Mar2025)

Phase IV Bipolar Depression trial by New York State Psychiatric Institute. Stop reason: OPERATIONAL.

Funding decision

Phase III Schizophrenia trial by Boehringer Ingelheim. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Healthy trial by Texas A&M University. Stop reason: OTHER/UNKNOWN.

Paused while the study is transferred from Baylor College of Medicine to Texas A\&M University.

Phase II Non-segmental Vitiligo trial by Merck Sharp & Dohme LLC. Stop reason: OPERATIONAL.

Business Reasons

Phase II Suicidal Ideation trial by University of Chicago. Stop reason: OTHER/UNKNOWN.

PI has left the university

Phase III Autism trial by Massachusetts General Hospital. Stop reason: OTHER/UNKNOWN.

requested by the IRB

Phase I Depression, Unipolar trial by Jay Fournier. Stop reason: OPERATIONAL.

This study never started enrollment at this site. Delays in establishing the infrastructure for this project resulted in the funds no longer being available at this time. Should additional funds be secured, a separate study will be registered here.

Phase IV Treatment-resistant Schizophrenia trial by Ohio State University. Stop reason: OPERATIONAL.

Not able to recruit enough subjects

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Early study termination due to insufficient efficacy.

Early Phase I Kava trial by Masonic Cancer Center, University of Minnesota. Stop reason: OTHER/UNKNOWN.

Drug expiration testing

Phase IV Schizophrenia trial by University of Miami. Stop reason: OPERATIONAL.

Recruitment issues

Phase IV Agitation trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Study did not start - due to funding issues prior to IRB approval

Phase II Treatment Resistant Depression trial by Axsome Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

This study was terminated once overall program objectives were met.

Phase IV Treatment Resistant Depression trial by Jonathan A. Javitch, MD, PhD. Stop reason: OPERATIONAL.

Inadequate recruitment

Phase IV Depression trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

low enrollment

Phase II Schizophrenia trial by VA Office of Research and Development. Stop reason: OPERATIONAL.

Inadequate Subject Recruitment

Phase II Attention-Deficit/Hyperactivity Disorder (ADHD) trial by Neurocentria, Inc.. Stop reason: OPERATIONAL.

Slow enrollment

Phase II ADHD trial by Neurocentria, Inc.. Stop reason: OPERATIONAL.

Slow enrollment

Phase II Schizophrenia trial by Beth Israel Deaconess Medical Center. Stop reason: OPERATIONAL.

Difficulty with recruiting subjects for the study

Phase II Bipolar Disorder trial by Biohaven Therapeutics Ltd.. Stop reason: OPERATIONAL.

Business Decision

Phase II Irritability Associated With Autism Spectrum Disorder trial by ACADIA Pharmaceuticals Inc.. Stop reason: OPERATIONAL.

The study was terminated for business reasons and not due to safety concerns.

Phase III Social Anxiety Disorder trial by VistaGen Therapeutics, Inc.. Stop reason: OPERATIONAL.

Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B

Phase II Major Depressive Disorder trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

we were not able to get the study drug due to covid

Phase III Major Depressive Disorder trial by Levomecor Inc.. Stop reason: OTHER/UNKNOWN.

Program Discontinued

Phase III Major Depressive Disorder trial by Levomecor Inc.. Stop reason: OTHER/UNKNOWN.

Program Discontinued

Phase II Postpartum Depression trial by Washington University School of Medicine. Stop reason: OTHER/UNKNOWN.

PI is leaving the university

Phase III Social Anxiety Disorder trial by VistaGen Therapeutics, Inc.. Stop reason: OPERATIONAL.

Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B

Phase III Schizophrenia trial by AbbVie. Stop reason: OTHER/UNKNOWN.

Strategic considerations

Phase III Schizophrenia trial by Northwestern University. Stop reason: OPERATIONAL.

unable to secure additional funding

Unknown Depressive Disorder, Treatment-Resistant trial by The Royal's Institute of Mental Health Research. Stop reason: OPERATIONAL.

The study was terminated prematurely due to significant recruitment challenges.

Phase I Major Depressive Disorder (MDD) trial by AbbVie. Stop reason: OPERATIONAL.

Company Decision

Phase II Depression - Major Depressive Disorder trial by Mclean Hospital. Stop reason: OTHER/UNKNOWN.

PI transferred to a different research institution and local institution would not allow to continue the study. Transfer of the study to a different study site not possible because of unique requirements of resources (e.g., nociceptin anatagonist)

Unknown Psychiatry trial by Centre Hospitalier Universitaire Dijon. Stop reason: OPERATIONAL.

because of the Covid pandemic, group meditation could not be carried out and was not repeated in the study.

Phase IV Autism Spectrum Disorder trial by University of Chicago. Stop reason: OPERATIONAL.

lack of funding and difficulty with phlebotomy in children with Autism

Phase II Acute Stress Disorder trial by Nationwide Children's Hospital. Stop reason: OPERATIONAL.

Unable to obtain funding to initiate/complete study

Phase II Adolescent Suicide trial by Yale University. Stop reason: OPERATIONAL.

Terminated early due to concerns from the NIH DSMB regarding the rate of recruitment and the resulting inability to accomplish the initially approved study aims

Phase IV ADHD trial by Milton S. Hershey Medical Center. Stop reason: OPERATIONAL.

challenge in recruitment\]

Phase III Schizophrenia trial by ACADIA Pharmaceuticals Inc.. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II PTSD - Post Traumatic Stress Disorder trial by Johns Hopkins University. Stop reason: OTHER/UNKNOWN.

Study is being conducted externally.

Phase II PTSD trial by Resilient Pharmaceuticals. Stop reason: OPERATIONAL.

The study was terminated early by the sponsor due to administrative, non-safety related reasons.

Phase I Major Depressive Disorder trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase I Major Depressive Disorder trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase I Major Depressive Disorder trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Unknown Major Depressive Disorder trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase II Schizophrenia trial by Neurocrine Biosciences. Stop reason: EFFICACY/FUTILITY.

Failed to meet the primary endpoint

Unknown COPD trial by Duke University. Stop reason: OPERATIONAL.

COVID-19 hold

Phase II Major Depressive Disorder trial by National Institute of Mental Health (NIMH). Stop reason: OPERATIONAL.

due to low recruitment

Phase III Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: SAFETY.

42847922MDD3002 was stopped based on the interim analysis (IA) results as recommended by the Independent Data Monitoring Committee (IDMC)

Phase III Autism Spectrum Disorder trial by University of Missouri, Kansas City. Stop reason: OTHER/UNKNOWN.

The PI is retiring.

Phase IV Bipolar Disorder trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Due to limited study staff and the COVID-19 pandemic, enrollment has been paused as staff hours for this project have been reduced and reallocated to other projects.

Phase III Bipolar I Disorder trial by University of British Columbia. Stop reason: OPERATIONAL.

Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding.

Phase I Peripheral Nerve Block trial by University of Pennsylvania. Stop reason: OPERATIONAL.

terminated due to lack of resources

Phase III Suicide trial by Naval Medical Center Camp Lejeune. Stop reason: OPERATIONAL.

As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service.

Phase II Schizophrenia trial by Boehringer Ingelheim. Stop reason: OPERATIONAL.

disruption due to COVID-19

Phase II Focal Segmental Glomerulosclerosis (FSGS) trial by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Stop reason: OPERATIONAL.

Problems with drug supply

Phase II Acute Post-operative Pain trial by Scripps Health. Stop reason: OPERATIONAL.

Enrollment was extremely low and there were too many adverse events.

Phase II Attention Deficit Hyperactivity Disorder (ADHD) trial by Supernus Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Financial decision

Phase II Depression trial by Janssen Research & Development, LLC. Stop reason: OPERATIONAL.

Study was terminated due to sponsor portfolio decision.

Phase III Depressive Disorder, Treatment-Resistant trial by Janssen-Cilag International NV. Stop reason: OPERATIONAL.

New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study

Phase I Depressive Disorder, Major trial by Janssen Research & Development, LLC. Stop reason: OTHER/UNKNOWN.

Following discussion on pediatric strategy with HAs, it was determined that we have sufficient data to inform next steps for the seltorexant pediatric program.

Phase I Depression trial by Janssen Research & Development, LLC. Stop reason: OPERATIONAL.

due to budget decision and wanting to pursue other research priorities

Phase II PTSD, Post Traumatic Stress Disorder trial by University of California, Los Angeles. Stop reason: OTHER/UNKNOWN.

Under review with FDA

Phase III Schizophrenia trial by Lyndra Inc.. Stop reason: OTHER/UNKNOWN.

Sponsor stopped operations

Phase I Postpartum Depression trial by Verinder Sharma. Stop reason: OTHER/UNKNOWN.

This study was pivoted to be a randomized control trial of trazodone versus quetiapine, under a new NTC identification number (study protocol number 125638).

Phase I Schizophrenia trial by Washington University School of Medicine. Stop reason: OPERATIONAL.

Study recruitment milestones were not met.

Phase II Autism Spectrum Disorder (ASD) trial by Massachusetts General Hospital. Stop reason: OTHER/UNKNOWN.

Due to a change in the research priorities of the principal investigator in combination with low subject interest.

Phase II Maternal Behavior trial by Lane Strathearn, MBBS PhD. Stop reason: OPERATIONAL.

Unable to recruit proposed study sample size due to COVID restrictions.

Unknown Major Depressive Disorder trial by University Hospital, Montpellier. Stop reason: OTHER/UNKNOWN.

no more inclusion

Phase I Schizophrenia trial by Central Institute of Mental Health, Mannheim. Stop reason: OPERATIONAL.

Lack of funding

Phase III Schizophrenia trial by Sumitomo Pharma Co., Ltd.. Stop reason: OPERATIONAL.

Due to company business strategy

Phase II Focal Segmental Glomerulosclerosis trial by Amgen. Stop reason: OTHER/UNKNOWN.

Program not advancing

Phase III Depressive Episodes, Bipolar I Depression trial by Sumitomo Pharma America, Inc.. Stop reason: OPERATIONAL.

Company decided not to move forward with further accrual.

Phase II Postpartum Depression trial by GH Research Ireland Limited. Stop reason: OPERATIONAL.

Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.

Phase II Bipolar II Disorder trial by GH Research Ireland Limited. Stop reason: OPERATIONAL.

Recruitment of this patient population was more challenging than anticipated. The sponsor concluded that a sufficient amount of patients have completed the trial to demonstrate proof of concept in this patient population.

Phase II Cocaine Addiction trial by Salvatore Campanella. Stop reason: OPERATIONAL.

Difficulties in recruitment (single addictions become rare)

Phase III Major Depressive Disorder (MDD) trial by MGGM LLC. Stop reason: OTHER/UNKNOWN.

The study was withdrawn based on business-related matters and there are no new safety concerns related to the trial. No patients were enrolled.

Phase III PTSD trial by Tonix Pharmaceuticals, Inc.. Stop reason: EFFICACY/FUTILITY.

Interim Analysis results

Phase III PTSD trial by Tonix Pharmaceuticals, Inc.. Stop reason: OTHER/UNKNOWN.

Stopped early due to inadequate separation on primary efficacy endpoint in the lead-in HONOR study, TNX-CY-P301

Phase IV Pediatric Bipolar Disorder trial by Massachusetts General Hospital. Stop reason: OPERATIONAL.

Slow subject recruitment.

Phase II Schizophrenia trial by Central Institute of Mental Health, Mannheim. Stop reason: OTHER/UNKNOWN.

Following the expiry of the original research grant, no follow-up financing could be provided to complete the study.

Phase III Schizophrenia trial by Otsuka Pharmaceutical Development & Commercialization, Inc.. Stop reason: OTHER/UNKNOWN.

Study terminated early, main goals achieved

Phase II Schizophrenia trial by Bjorn H. Ebdrup. Stop reason: OPERATIONAL.

Drug supply withdrawn (dec 2019)

Phase I Major Depressive Disorder trial by Davidzon, Guido, M.D.. Stop reason: OPERATIONAL.

We did not receive grant funding for this study.