Cysteamine Therapy for Major Depressive Disorder

NCT00715559 | Terminated Results

• 1 other identifier: GCO # 07-0478
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder, depression; neurotrophic; brain-derived neurotrophic factor; antidepressant; cysteamine

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.

  8 weeks

Secondary Outcomes (3)

• Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)

  8 weeks

• Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)

  8 weeks

• Systematic Assessment for Treatment Emergent Effects (SAFTEE)

  weekly, for 8 weeks

Study Arms (1)

cysteamine bitartrate

EXPERIMENTAL

Participants received cysteamine bitartrate by mouth up to 300 mg three times daily.

Drug: cysteamine bitartrate

Interventions

cysteamine bitartrate DRUG

All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients without intolerable side effects will increase the dose to 300 mg three times daily. The titration schedule will continue up to a maximum of 1800 mg a day. In case of adverse events, the investigator may decrease the dose by 150 mg daily.

cysteamine bitartrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Cysteamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mercaptoethylamines; Ethylamines; Amines; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds

Results Point of Contact

• Title: Dr. James Murrough
• Organization: Mount Sinai School of Medicine

james.murrough@mssm.edu

212-241-7574

Study Officials

• James Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 7, 2017
• Results First Posted: June 16, 2011

Record last verified: 2017-04

Locations

US (1)