The Serotonin Transporter's Role in Ketamine's Antidepressant Effects.

Phase 1

• Conditions: 20 patients with severe unipolar depression (structured clinical interview for DSM-IV and the 17-item Hamilton Depression Rating Scale), also 20 age and sex matched healthy controls. plus 12 HC for pilot study I.plus 10 HC for pilot study II.plus 12 HC for pilot study III.plus 30 HC for study sub-study.Drop-outs will be replaced with newly recruited subjects until the number of subjects listed above have completed the study portion they are participating in according to protocol.; MedDRA version: 21.1Level: LLTClassification code 10045543Term: Unipolar depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-003280-38-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

-Men and women aged 18-55
-Participants free from internal medicine or neurologic diseases
-Negative pregnancy test at the screening visit and before PET visits (only women)
-Participants must be willing and able to give informed consent
-Severe unipolar depression tested with a structured clinical interview for DSM-IV (SCID) and HAM-D (only patients)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Severe medical or neurologic disorder
-Psychiatric disorder (only in healthy controls)
-DSM-IV Axis-1 comorbidity other than anxiety symptoms (only patients)
-Clinically relevant alterations in blood draw (hematology, blood chemistry) or standard physical examination
-Addiction to alcohol or another substance (current or past)
-Intake of psychopharmaceutical medication in the last 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified