Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT00040261
Eligibility Criteria:
INCLUSION CRITERIA:
Subjects may be included in the study only if they meet all of the following criteria:
Male or female subjects, 18 to 80 years of age.
Female subjects of childbearing potential must be using a medically accepted means of contraception.
Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol.
Subjects must be considered reliable.
Each subject must understand the nature of the study and must sign an informed consent document.
Subjects must fulfill the criteria for major depression, recurrent without psychotic features as defined in DSM-IV based on clinical assessment and confirmed by structured diagnostic interview SCID-P.
Subjects must have an initial score at Visit 1 and Visit 2 of at least 22 on the MADRS.
Subjects must not have a decrease in the total score of MADRS of greater than 20 % during washout (between Visits 1 and 2).
Current major depressive episode of at least 4 weeks duration.
EXCLUSION CRITERIA:
Subjects will be excluded from the study for any of the following reasons:
Lack of response to more than 2 antidepressants (adequate dose and duration).
Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (Visit 1).
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.
Documented history of hypersensitivity or intolerance to amantadine or prior treatment with memantine.
DSM-IV substance abuse or dependence (except nicotine and caffeine) within the past 90 days.
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to Visit 2.
Treatment with a reversible monoamine oxidase inhibitor, guanethidine, or guanadrel within 1 week prior to Visit 2.
Treatment with fluoxetine within 6 weeks prior to Visit 2.
Treatment with any other concomitant medication with primarily CNS activity.
Treatment with clozapine within 4 weeks prior to Visit 2.
Treatment with amitriptyline (elavil) within 4 weeks prior to Visit 2 since amitriptyline and similar TCAs may manifest a mild NMDA receptor antagonism, as demonstrated in electrophysiological studies.
Treatment with the anticonvulsants carbamazepine (tegretol, carbatrol, tegretol XR and similar derivatives), gabapentin (neurontin) or felbamate (felbatol) within 4 weeks prior to Visit 2 because these drugs may interfere with NMDA receptor function.
Treatment with electroconvulsive therapy (ECT) within 3 months (90 days) prior to Visit 2.
Current diagnosis of schizophrenia or other psychotic or bipolar disorder as defined in the DSM-IV.
Judged clinically to be at serious suicidal risk.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00040261
Study Brief:
Protocol Section:
NCT00040261