Ketamine in Adolescents With Treatment-Resistant Depression

NCT02078817 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 22225
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the use of ketamine for treatment of depression in adolescents that have not responded to other treatments. We will also examine neurobiological mechanisms of treatment.

Conditions

Major Depressive Disorder

Keywords

Treatment-resistant

Outcome Measures

Primary Outcomes (1)

• Number of Responders Measured by Clinical Global Impression (CGI)

  Responders will be defined as those with CGI ratings (given by the study clinician) of 1 or 2 (much or very much improved). Patients that are given a scores of 3-7 (minimally improved to very much worse) will be considered non-responders.

  2 weeks

Secondary Outcomes (8)

• Children's Depression Rating Scale-Revised

  2 weeks

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  2 weeks

• Beck Depression Inventory-II (BDI-II)

  2 weeks

• Change in Clinician Administered Dissociative States Scale (CADSS)

  baseline, 2 weeks

• Maximum Change in Systolic Blood Pressure

  2 hours and 40 minutes

Study Arms (1)

ketamine

EXPERIMENTAL

Intravenous ketamine 0.5 mg/kg over 40 minutes will be given 6 times over 2 weeks.

Drug: Ketamine

Interventions

Ketamine DRUG

IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.

ketamine

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female adolescents aged 12 to 18 years.
• Presence of recurrent major depression without psychotic features confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia - Parent and Lifetime Version (Kaufman et al., 1997).
• Current depression severity measured by the Children's Depression Rating Scale (CDRS) (Poznanski, 1985) raw score greater than or equal to 36 at screening and the day ketamine is due to be received for the first time.
• Current depressive episode resistant to treatment, defined as failure to achieve remission (elimination of symptoms and restoration of pre-morbid psychosocial functioning) from at least 2 antidepressant trials of different pharmacological classes. Systematic evaluation of previous antidepressant trials will be assessed by using the Antidepressant Treatment History Form (Sackeim, 2001).
• If present, current antidepressant medication treatment must be dose stable for at least 2 months prior to beginning the study. (Patients will continue with current antidepressant treatment throughout the study. Based on our experience in current research at the VA Medical Center using serial ketamine for adult TRD, patients have shown positive results while continuing their current antidepressant treatment.)

You may not qualify if:

• Inability to speak English
• Inability or unwillingness to provide written informed consent
• A history of Mental Retardation or any Pervasive Developmental Disorder
• Current or lifetime diagnosis of schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified.
• Family history with a first degree relative with schizophrenia, schizoaffective disorder, or psychosis Not Otherwise Specified.
• Diagnosis of seizures or other neurological disorders.
• Comorbid diagnosis of substance abuse or dependence, current or past.
• Clinically unstable medical illness.
• Current use of the following medications: any barbiturates, any narcotics, any non-benzodiazepine hypnotics at doses higher than zolpidem 10 mg qhs or equivalent for insomnia.
• For women: pregnancy (confirmed by baseline lab test).
• The presence of any MRI contra-indications such as MRI-incompatible metals in the body or claustrophobia.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Roy AV, Thai M, Klimes-Dougan B, Westlund Schreiner M, Mueller BA, Albott CS, Lim KO, Fiecas M, Tye SJ, Cullen KR. Brain entropy and neurotrophic molecular markers accompanying clinical improvement after ketamine: Preliminary evidence in adolescents with treatment-resistant depression. J Psychopharmacol. 2021 Feb;35(2):168-177. doi: 10.1177/0269881120928203. Epub 2020 Jul 9.

  PMID: 32643995 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Katherine Cullen
• Organization: University of Minnesota

rega0026@umn.edu

612-273-9732

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 5, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Locations

US (1)