Status:
TERMINATED
Cysteamine Therapy for Major Depressive Disorder
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression.
Detailed Description
Major depressive disorder (MDD) is a chronic, disabling illness affecting about 17% of the general population. Despite advances in treatment, about two-thirds of patients fail to respond to an initial...
Eligibility Criteria
Inclusion
- Male or female patients, 21-65 years of age.
- Female subjects who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or must be using a medically accepted means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative serum B-HCG at pre-study.
- Subjects must fulfill DSM-IV criteria for Major Depression without psychotic features, based on clinical assessment by a study psychiatrist and confirmed by a structured diagnostic interview, the Structured Clinical Interview for DSM-IV TR Axis I Disorders, (SCID-P).
- Subjects have a history of at least one previous episode of depression prior to the current episode (recurrent major depressive disorder) or have chronic major depressive disorder (at least two years' duration).
- Subjects have not responded to an adequate trial of one antidepressant in the current episode as determined by Antidepressant Treatment History Form (ATHF) criteria (score \> 3) (Sackeim 2001)
- Subjects must have an initial score of ³ 32 on the IDS-C at both Visit 1 and Visit 2.
- Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
- Current major depressive episode is of at least 4 weeks duration
Exclusion
- Presence of psychotic features, diagnosis of schizophrenia or any other psychotic disorder, or bipolar disorder/cyclothymia as defined in the DSM-IV.
- Lifetime histories of autism, mental retardation, pervasive developmental disorders, OCD, or Tourette's
- Current Eating Disorder
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease.
- Hypersensitivity to cysteamine or penicillamine
- Past history of severe gastrointestinal disease (including peptic ulcers or inflammatory bowel disease), or current gastroesophageal reflux disease
- Subjects with a history of neutropenia or medication-induced blood dyscrasia.
- Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
- Subjects with one or more seizures without a clear and resolved etiology.
- Treatment with a reversible MAOI within 2 weeks prior to Visit 2.
- Treatment with fluoxetine within 4 weeks prior to Visit 2.
- Treatment with any other concomitant medication not allowed 14 days prior to study Visit 2.
- Treatment with clozapine or ECT within 3 months prior to study Visit 2.
- Judged clinically to be at serious suicidal or homicidal risk.
- Participation in a clinical trial of another investigational drug within 1 month prior to study entry.
- Patients starting hormonal treatment (e.g., estrogen) in the last 3 months prior to visit 1.
- Psychotherapy or nonpharmacological antidepressant treatments (e.g. light therapy
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00715559
Start Date
July 1 2008
End Date
May 1 2009
Last Update
April 7 2017
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029