To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD

NCT02398136 | Withdrawn Phase 2 DMC

• 1 other identifier: GCO 14-1781
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD.

Conditions

PTSD

Keywords

intervention; ketamine; PTSD; treatment; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• Impact of Events Scale-Revised (IES-R)

  The IES-R is used to self-report measures of stress reactions to traumatic events. It measures both intrusion and avoidance.

  24 hours

Secondary Outcomes (5)

• Clinician Administered PTSD Scale (CAPS)

  up to 4 weeks

• Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)

  24 hours

• Montgomery Asberg Depression Rating Scale (MADRS)

  24 hours

• Patient-Rated Inventory of Side Effects (PRISE)

  24 hours

• Sheehan Disability Scale (SDS)

  24 hours

Study Arms (2)

Ketamine

EXPERIMENTAL

Intranasal ketamine up to 75 mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

Intranasal midazolam 3.75mg, delivered over 20 minutes, frequency: 3x/week for 4 weeks.

Drug: Midazolam

Interventions

Ketamine DRUG

Also known as: Intranasal ketamine

Ketamine

Midazolam DRUG

Also known as: Placebo

Midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, 18-65 years of age;
• Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document;
• Participants must fulfill DSM-5 criteria for current civilian or combat-related PTSD, based on clinical assessment by a study psychiatrist and on the CAPS -this is done to ensure at least moderate severity and to safeguard against high placebo response rates;
• Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year);
• Women of childbearing potential must have a negative pregnancy test at screening and prior to each intranasal administration;
• Participants must be able to identify a family member, physician, or friend (i.e. someone who knows them well) who will participate in a Treatment Contract (and e.g. contact the study physician on their behalf in case manic symptoms or suicidal thoughts develop).

You may not qualify if:

• Women who plan to become pregnant, are pregnant or are breast-feeding (because the medical risk of using ketamine during pregnancy and breast-feeding is unknown);
• Serious, unstable medical illnesses such as hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, including gastro-esophageal reflux disease, obstructive sleep apnea, history of difficulty with airway management during previous anesthetics, ischemic heart disease and uncontrolled hypertension, and history of severe head injury;
• Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
• Patients with uncorrected hypothyroidism or hyperthyroidism;
• Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first intranasal administration day;
• Use of evidence-based individual psychotherapy (such as prolonged exposure) during the study;
• History of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
• History of one or more seizures without a clear and resolved etiology;
• History of (hypo)mania;
• Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia or schizoaffective disorder;
• Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their PTSD, and to more closely approximate patients seen in real-world settings; this is the same period of time that we used in our recently completed study of IV ketamine for PTSD.
• Previous recreational use of ketamine or PCP;
• Current diagnosis of bulimia nervosa or anorexia nervosa;
• Diagnosis of schizotypal or antisocial personality disorder (since these are known to reduce the possibility of study completion); other Axis II diagnoses will be allowed;
• Patients judged clinically to be at serious and imminent suicidal or homicidal risk.

Sponsors & Collaborators

• Adriana Feder: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adriana Feder, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: March 25, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03