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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for pcl, change in scores at 25th hour post-infusion compared to the baseline were measured

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change from baseline scores on the Beck Anxiety Scale at 25th hours post-infusion

Change from baseline scores on the Hamilton depression rating scale (17-item version) 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor

75 Previous Clinical Trials

24,063 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this research endeavor?

"This trial is recruiting 50 individuals who suffer from PTSD, aged 21 to 60. Potential participants must meet the DSM-IV criteria for Post Traumatic Stress Disorder and possess a PCL-C score of at least 51 or higher on the CAPS scale first 17 items. Both male and female candidates are accepted, with reproductive capable women required to use reliable contraception or be postmenopausal for one year already. All participants must also remain stable on their current medications throughout the duration of this experiment."

Answered by AI

Are there any vacancies available for those wishing to participate in this medical investigation?

"According to the public information on clinicaltrials.gov, this specific trial is no longer recruiting new participants after having been initially posted on August 1st 2013 and last updated in May 2016. However, there are 515 other studies actively enrolling patients at present."

Answered by AI

What is the current rate of enrollment into this trial?

"As of now, this research is not accepting participants. The trial was initially published on August 1st 2013 and last revised on May 5th 2016. If you are searching for other studies involving Post Traumatic Stress Disorder (PTSD), there are currently 410 open clinical trials and 105 opportunities to partake in TIMBER Psychotherapy."

Answered by AI