Major Depressive DisorderNCT00715559
Cysteamine Therapy for Major Depressive Disorder
A study testing cysteamine bitartrate in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- cysteamine bitartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: An Open-Label Study of Cysteamine Bitartrate in Treatment-Resistant Major Depression
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.
Read the 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 trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in the central nervous system, and has been implicated in the pathophysiology and potential treatment of MDD. A multitude of studies have shown low levels of BDNF in subjects with MDD, which have normalized after treatment with an antidepressant. Traditional antidepressants such as serotonin reuptake inhibitors may increase BDNF via an indirect intracellular pathway. The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis and has been shown to increase BNDF in neuronal tissue, and to stimulate cell growth. Cysteamine has already been investigated in humans as a potential treatment for Huntington's Disease. Given the evidence of decreased levels in major depression, and subsequent increase post-treatment with antidepressants, BDNF may play a key role in developing novel treatments for patients who have failed conventional agents. Therefore, drugs that can demonstrably increase central BDNF, such as cysteamine, may have significant potential as novel antidepressant medications.
- Conditions
- Major Depressive Disorder
- Being tested
- cysteamine bitartrate
- Keywords
- Major depressive disorder, depression, neurotrophic, brain-derived neurotrophic factor, antidepressant, cysteamine
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cysteamine bitartrateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| cysteamine bitartrate | Experimental | Participants received cysteamine bitartrate by mouth up to 300 mg three times daily. Receives: Drug: cysteamine bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)
This set of scales measures "global" improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse.
Measured: 8 weeks
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)
This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).
Measured: 8 weeks
Systematic Assessment for Treatment Emergent Effects (SAFTEE)
The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is "mild" "moderate" or "severe." The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of "moderate" or "severe" that also represented a change from a baseline-line pre-intervention SAFTEE assessment.
Measured: weekly, for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Change in resources available for study procedures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Murrough, Icahn School of Medicine at Mount Sinai
- Investigators
- James Murrough, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715559
- Sponsor's protocol ID
- GCO # 07-0478
- Status last verified
- Apr 2017
- First submitted
- 11 Jul 2008
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Cysteamine Bitartrate in Treatment-Resistant Major Depression
- ClinicalTrials.gov ID
- NCT00715559
- Acronym / sponsor ID
- GCO # 07-0478
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, depression, neurotrophic, brain-derived neurotrophic factor, antidepressant, cysteamine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in resources available for study procedures.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 16 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in the central nervous system, and has been implicated in the pathophysiology and potential treatment of MDD. A multitude of studies have shown low levels of BDNF in subjects with MDD, which have normalized after treatment with an antidepressant. Traditional antidepressants such as serotonin reuptake inhibitors may increase BDNF via an indirect intracellular pathway. The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis and has been shown to increase BNDF in neuronal tissue, and to stimulate cell growth. Cysteamine has already been investigated in humans as a potential treatment for Huntington's Disease. Given the evidence of decreased levels in major depression, and subsequent increase post-treatment with antidepressants, BDNF may play a key role in developing novel treatments for patients who have failed conventional agents. Therefore, drugs that can demonstrably increase central BDNF, such as cysteamine, may have significant potential as novel antidepressant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cysteamine bitartrate | Experimental | Drug: cysteamine bitartrateParticipants received cysteamine bitartrate by mouth up to 300 mg three times daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cysteamine bitartrateAll 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. | Drug | cysteamine bitartrate |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.
3 secondary outcomes
Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)
Time frame: 8 weeks
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)
Time frame: 8 weeks
Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Time frame: weekly, for 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Murrough, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cysteamine bitartrate in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.