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NMDA Receptor Antagonist

TIMBER Therapy + Ketamine for PTSD

N/A
Waitlist Available
Led By Basant Pradhan, MD
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must be using a medically accepted reliable means of contraception (oral contraceptive medication etc.) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year)
Men or women, 21-60 years of age
Must not have
Meet criteria for psychotic disorders, e.g. schizophrenia/schizoaffective disorder
History of one or more seizures without a clear and resolved etiology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured
Awards & highlights

Summary

This trial is testing a combination of ketamine and TIMBER therapy to see if it's more effective than TIMBER therapy alone in treating PTSD.

Who is the study for?
Adults aged 21-60 with chronic PTSD, who understand the study and consent to participate. They must meet specific PTSD criteria, have stable medication dosages, and use reliable contraception if applicable. Excluded are those with certain mental or severe physical health issues, history of ketamine misuse, pregnancy or breastfeeding women, and recent substance abuse.
What is being tested?
The trial is testing a combination of TIMBER Psychotherapy with either a single low dose of Ketamine or placebo (saline). The goal is to see if this approach can effectively treat chronic PTSD symptoms by targeting trauma memories using both pharmacological and psychotherapeutic methods in a controlled setting.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from ketamine may include disorientation, dizziness, nausea, increased blood pressure and heart rate. Psychological effects could be anxiety or changes in mood. Side effects from psychotherapy are generally minimal but can include emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either not able to have children or I am using reliable birth control.
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I am between 21 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a psychotic disorder, like schizophrenia.
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I have had seizures with no known cause.
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I have no major abnormal lab results or physical exam findings.
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My thyroid condition is not currently managed.
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I do not have any serious, unstable illnesses affecting major body systems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured
This trial's timeline: 3 weeks for screening, Varies for treatment, and for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline scores on the Clinician Administered PTSD Scale (CAPS) at 25th hours post-infusion
Change from baseline scores on the PTSD Symptom Checklist (PCL, self-reported) at 25th hours post-infusion

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TIMBER-Ketamine armExperimental Treatment2 Interventions
This arm received TIMBER psychotherapy and ketamine infusion.
Group II: TIMBER-placebo armPlacebo Group2 Interventions
This arm received TIMBER psychotherapy and placebo (normal saline) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
80 Previous Clinical Trials
35,478 Total Patients Enrolled
Basant Pradhan, MDPrincipal InvestigatorCooper Health System

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02766192 — N/A
Post-Traumatic Stress Disorder Research Study Groups: TIMBER-placebo arm, TIMBER-Ketamine arm
Post-Traumatic Stress Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT02766192 — N/A
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02766192 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT02766192 — N/A
~4 spots leftby Sep 2025
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