Ketamine-assisted psychotherapy for Depression (KReDO Trial)

Phase 2

Waitlist Available

Led By Eric T Dobson, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if ketamine shots combined with talking therapy can help people with past opioid addiction who are now depressed. Ketamine quickly changes brain activity to improve mood, while therapy helps manage emotions. Ketamine is used in treating multiple pain, mental health, and substance abuse disorders due to its rapid-acting pain relief and mood improvement effects.

Eligible Conditions

Depression
Addiction
Recovered from addiction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montgomery Asberg Depression Rating Scale

Secondary study objectives

Beck Depression Inventory

Brief Pain Inventory (BPI)

Generalized Anxiety Disorder-7 (GAD-7)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketamine-assisted psychotherapyExperimental Treatment1 Intervention

Subjects will receive 8 weekly intramuscular injections of ketamine hydrochloride starting at 0.5 mg/kg and increasing to a maximum dose of 1.5 mg/kg or a total dose of 60 mg, whichever is lower. Ketamine administration will be accompanied by psychotherapy before, after and during the session.

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