Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471818
Other study ID # (019/024/CPI) /CEI/1332/18)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 19, 2019
Est. completion date July 30, 2023

Study information

Verified date September 2023
Source Instituto Nacional de Cancerologia de Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1). MD is a frequent complication in patients who are diagnosed with advanced cancer.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date July 30, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age: 18 to 65 years of age 2. Sex: Male or female 3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 4. Palliative stage cancer diagnosis (advanced-disease stage) 5. Who can read and write in spanish 6. Eastern Cooperative Oncology Group (ECOG) 0-2 7. Karnofsky = 50 8. Palliative prognostic index A 9. Not currently undergoing systemic oncologic treatment 10. Patients who agree to participate in the study by signing an informed consent. Exclusion Criteria: 1. Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder). 2. Magnetic resonance or computerized tomography with major structural alterations. 3. Pregnant or breastfeeding women. 4. Patients with hypersensitivity to ketamine 5. Cardiac insufficiency 6. Patients with a history of psychosis 7. Patients with first-degree relatives with a history of psychosis 8. Patients with uncontrolled glaucoma 9. Current neurological illness

Study Design


Intervention

Drug:
Ketamine
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Other:
Placebo
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Locations

Country Name City State
Mexico Instituto Nacional de Cancerología (INCan) Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Edinburg Depression Scale (BEDS) score Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring =7 in this scale. 3 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A