Cysteamine Therapy for Major Depressive Disorder

Stopped early · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00715559

Run by

Icahn School of Medicine at Mount Sinai

People needed

3

Starts

2008-07-01

Expected to finish

2009-05-01

Last updated by the study team

2017-04-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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