DRKS00003527CompletedPhase 2
Ketamine in treatment resistant major depression (TRD) -A placebo controlled, double blind, randomized trial of efficacy, safety and response prediction by resting state fMRI - KETREST
Otto-von-Guericke University MagdeburgMedical Faculty0 sites91 target enrollmentStarted: March 7, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 91
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •TRD subjects must satisfy the following criteria before entering the study:
- •Male or female subjects between 18 and 55 years of age, inclusive.
- •Subjects must fulfill ICD-10 for recurrent Major Depression (F 33) without psychotic
- •features, based on clinical assessment and confirmed by structured diagnostic interview.
- •Subjects must have an initial score of at least 16 on the 21-item HAMD at screen and at
- •baseline of study phase I.
- •Current history of lack of response to two adequate antidepressant trials (may be from
- •the same chemical class) operationally defined using the Antidepressant Treatment History Form (ATHF).
- •Current major depressive episode of at least 4 weeks duration.
- •Both healthy controls and TRD subjects must fulfill the following criteria:
- •Women of childbearing potential must have a negative pregnancy test on the day of each
- •scan, prior to participating in MRI imaging part of the study.
- •Healthy or medically stable on the basis of clinical laboratory tests performed at
- •Healthy or medically stable on the basis of physical examination, medical history, vital signs (including
- •orthostasis test) or 12 lead ECG (including QTcB <470 ms) at Screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator are acceptable.
- •Willing to adhere to the prohibitions and restrictions specified in this protocol.
- •Subjects must have signed an informed consent document indicating that they
- •understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria
- •Potential TRD subjects who meet any of the following criteria will be excluded from participating in the study:
- •Current or past history of psychotic features or a diagnosis of Schizophrenia or any other
- •psychotic disorder as defined in the ICD-10.
- •Potential healthy control subjects who meet any of the following criteria will be excluded from participating in the study:
- •Current or past history of psychotic features or a diagnosis of any psychiatric disorder as defined in the ICD-10.
- •Both TRD subjects and healthy control subjects who meet any of the following criteria will be excluded from participating in the study:
- •Subjects with a history of drug or alcohol dependency or abuse within the preceding 6 months.
- •Female subjects who are either pregnant or nursing.
- •Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory,
- •cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
- •immunologic, or hematologic disease.
- •Subjects with uncorrected hypothyroidism or hyperthyroidism.
- •Subjects with one or more seizures without a clear and resolved etiology.
- •Presence of metallic (ferromagnetic) implants (heart pacemaker, aneurysm clips) or
- •Subjects with any medical illness likely to alter brain morphology and/or physiology
- •(uncontrolled hypertension, diabetes) will be excluded.
- •Treatment with a reversible MAOI within 4 weeks prior to baseline assessment.
- •Treatment with clozapine or ECT within 3 months prior to baseline assessment.
- •Judged clinically to be at serious suicidal risk.
- •Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola per day.
- •Use of energy drinks within 3 days before the baseline assessment and during the
- •duration of the study.
- •Clinically significant acute illness within 7 days prior to study drug administration.
- •Clinically significant history of drug and/or food allergies.
- •Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an
- •equivalent amount of blood within 90 days prior to study drug administration.
- •Participation in another clinical trial (drug, medical device): Have received an experimental drug or used an experimental medical device within 90
- •days before the planned start of treatment.
Investigators
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