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Depressive Disorder, Treatment-ResistantPhase 1NCT02577250

Ketamine Infusions for PTSD and Treatment-Resistant Depression

A Phase 1 study testing Ketamine in people with Depressive Disorder, Treatment-Resistant and Stress Disorders, Post-Traumatic, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2015to Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female veterans aged 18 to 75 years.
  • Participants must have a telephone in their home and ability to hear telephone conversations.
  • Participants must meet current DSM-IV criteria for major depressive disorder (MDD), single or recurrent, without psychotic features
  • Participants must meet DSM-5 criteria for current post-traumatic stress disorder (PTSD) and have received a diagnosis of PTSD greater than or equal to 3 months prior to assessment.
  • Current major depressive episode resistant to treatment.
  • If applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.

Who cannot join

  • Inability to speak English
  • Inability or unwillingness to provide written informed consent
  • Moderate/severe cognitive impairment .
  • Current or lifetime diagnosis of psychosis-related disorder, bipolar I or II disorder, substance-induced mood disorder, or any mood disorder due to a general medical condition.
  • Current or lifetime diagnosis of a Cluster B disorder.
  • History of moderate or severe traumatic brain injury, Parkinson's disease, dementia of any type, multiple sclerosis, seizures or other CNS related disorders.
Show all 14Show fewer
  • History of comorbid substance disorder within 6 months of screening as assessed using the Mini International Neuropsychiatric Interview (MINI), plus positive urine toxicology screen test during baseline assessments.
  • Prior use of ketamine as an antidepressant.
  • Clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension)
  • Current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (MAOI).
  • History of antidepressant- or substance-induced hypomania.
  • History of first degree relative(s) with an Axis I psychotic disorder.
  • For women: pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study.
  • Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Minneapolis Va Health Care System, Minneapolis MN

    Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: Efficacy and Safety of Repeated Intravenous Subanesthetic Ketamine Infusions Among Veterans With Treatment Resistant Depression Comorbid With Chronic Post-Traumatic Stress Disorder: A Proof-of-concept Study

The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.

Read the detailed description

The proposed study is a pilot study designed to determine the efficacy and safety of serial ketamine infusions among veterans with treatment-resistant depression (TRD) as well as chronic post-traumatic stress disorder (PTSD). The investigators hypothesize that six infusions of ketamine will be effective in decreasing severity of depressive symptoms and maintaining response.

Participants will be male/female veterans (18 to 75 years old) of any era or military background who suffer from TRD and chronic PTSD. Potential participants will be recruited from Mental Health clinics and screened for eligibility using a two stage process (phone/chart review, followed by interview). Participants will receive six ketamine infusions on a Monday-Wednesday-Friday schedule over 2 weeks. On the day of infusion, participants will be required to stay at the clinical site for 3 hours after the medication has been given. Follow-up visits will occur at different time points over the course of 2 months after the two week infusion period has been completed.

Being tested
Ketamine
Keywords
ketamine, stress disorders, post-traumatic, stress disorders, traumatic, anxiety disorders, mental disorders, adjuvants, anesthesia, analgesics, anesthetics, anesthetics, dissociative, anesthetics, general, anesthetics, intravenous, excitatory amino acid agents, excitatory amino acid antagonists, hypnotics and sedatives, molecular mechanisms of pharmacological action, neurotransmitter agents, peripheral nervous system agents, pharmacologic actions, physiological effects of drugs, psychotropic drugs
Medical subject headings
Depressive Disorder, Treatment-Resistant, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Anxiety Disorders, Mental Disorders, Depression, Depressive Disorder, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.

Study groups in NCT02577250
Study groupRoleWhat they receive
Six ketamine infusionsExperimentalSix infusions of 0.5 mg/kg ketamine hydrochloride solution over 2 weeks.
Receives: Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured: 24 hours post-infusion

  2. Clinical-Administered PTSD Scale (CAPS)

    Measured: 2 weeks after the first infusion

Secondary outcomes (3)

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured: up to 2 months

  2. PTSD Checklist

    Measured: 24 hours post-infusion

  3. Clinical-Administered PTSD Scale (CAPS)

    Measured: up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577250
Sponsor's protocol ID
4555-B
Status last verified
May 2019
First submitted
9 Oct 2015
Last updated
14 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Albott CS, Lim KO, Forbes MK, Erbes C, Tye SJ, Grabowski JG, Thuras P, Batres-Y-Carr TM, Wels J, Shiroma PR. Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant Depression. J Clin Psychiatry. 2018 May/Jun;79(3):17m11634. doi: 10.4088/JCP.17m11634.

    PubMed 29727073

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ketamine in people with Depressive Disorder, Treatment-Resistant and Stress Disorders, Post-Traumatic, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 24 hours post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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