Major DepressionPhase 4NCT00296686
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
A Phase 4 study testing Tranylcypromine, Dextroamphetamine and Triiodothyronine in people with Major Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Tranylcypromine, Dextroamphetamine and Triiodothyronine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Ages between 18-65
- Major Depression
- At least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ECT trial (at least 8 bilateral treatments)
- Physically healthy
Who cannot join
- Known Tranylcypromine allergy
- Unable to follow tyramine-free diet
- Known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the Dextroamphetamine portion of the protocol
- Current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude Dextroamphetamine portion of the protocol
- Unable or unwilling to discontinue antidepressants including OTC antidepressants such as St. John's Wort
- History of psychosis, such as schizophrenia or psychotic depression; history of bipolar mania will be allowed if on adequate mood stabilizer
Show all 10Show fewer
- Suicidal ideation/activity that makes outpatient treatment unsafe, unless protocol can be conducted as inpatient
- Current systolic BP > 149 or diastolic BP > 89 mm Hg (two readings); adequately treated hypertension is acceptable
- Evidence of hypo- or hyperthyroidism
- Pregnancy, lactation, refusal to use adequate birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
Read the detailed description
This pilot study will recruit 40 patients with Major Depression and a history of at least two failed prior adequate somatic treatments. In addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose Tranylcypromine (i.e., max. 60 mg/d). Non-remitters will have dose increased to max. 120 mg/d if tolerated. Non-remitters to high dose Tranylcypromine will then have Dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. Non-remitters will have Triiodothyronine added to the Tranylcypromine.
- Conditions
- Major Depression
- Being tested
- Tranylcypromine, Dextroamphetamine, Triiodothyronine
- Keywords
- Major Depression, Refractory Depression, Tranylcypromine, Dextroamphetamine, Triiodothyronine
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranylcypromineDrug
Also called Parnate
standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks.
DextroamphetamineDrug
Also called Dexedrine
up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone.
TriiodothyronineDrug
Also called Cytomel
For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day).
| Study group | Role | What they receive |
|---|---|---|
| tranylcypromine | Experimental | sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3 Receives: Drug: Tranylcypromine; Drug: Dextroamphetamine; Drug: Triiodothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: up to 10 mos.
Secondary outcomes (3)
Beck Depression Inventory (BDI)
Measured: up to 10 mos.
Clinical Global Impression (CGI)
Measured: up to 10 mos.
Patient Global Impression (PGI)
Measured: up to 10 mos.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startSep 2001
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: Study is no longer funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W. Stewart, MD, Principal investigator, New York State Psychiatric Institute - Columbia University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296686
- Sponsor's protocol ID
- #4213
- Other IDs
- NCT00296686
- Status last verified
- Apr 2012
- First submitted
- 23 Feb 2006
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stewart JW, Deliyannides DA, McGrath PJ. How treatable is refractory depression? J Affect Disord. 2014;167:148-52. doi: 10.1016/j.jad.2014.05.047. Epub 2014 Jun 4.
PubMed 24972362
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
- ClinicalTrials.gov ID
- NCT00296686
- Acronym / sponsor ID
- #4213
- Conditions
- Major Depression
- Keywords
- Major Depression, Refractory Depression, Tranylcypromine, Dextroamphetamine, Triiodothyronine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is no longer funded.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
Detailed description
This pilot study will recruit 40 patients with Major Depression and a history of at least two failed prior adequate somatic treatments. In addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose Tranylcypromine (i.e., max. 60 mg/d). Non-remitters will have dose increased to max. 120 mg/d if tolerated. Non-remitters to high dose Tranylcypromine will then have Dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. Non-remitters will have Triiodothyronine added to the Tranylcypromine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tranylcypromine | Experimental | Drug: Tranylcypromine, Drug: Dextroamphetamine, Drug: Triiodothyroninesequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages between 18-65
- Major Depression
- At least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ECT trial (at least 8 bilateral treatments)
- Physically healthy
Key exclusion criteria (10 listed)
- Known Tranylcypromine allergy
- Unable to follow tyramine-free diet
- Known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the Dextroamphetamine portion of the protocol
- Current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude Dextroamphetamine portion of the protocol
- Unable or unwilling to discontinue antidepressants including OTC antidepressants such as St. John's Wort
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 |
|---|---|---|
| TranylcypromineAlso: Parnatestandard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks. | Drug | tranylcypromine |
| DextroamphetamineAlso: Dexedrineup to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone. | Drug | tranylcypromine |
| TriiodothyronineAlso: CytomelFor patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day). | Drug | tranylcypromine |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: up to 10 mos.
3 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: up to 10 mos.
Clinical Global Impression (CGI)
Time frame: up to 10 mos.
Patient Global Impression (PGI)
Time frame: up to 10 mos.
Results and safety
The study was stopped early (reason given: Study is no longer funded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- Derived from this study: PubMed 24972362Stewart JW, Deliyannides DA, McGrath PJ. How treatable is refractory depression? J Affect Disord. 2014;167:148-52. doi: 10.1016/j.jad.2014.05.047. Epub 2014 Jun 4.
- Depression Evaluation Service - official websiteLink provided by the sponsor.
- New York State Psychiatric Institute - official websiteLink provided by the sponsor.
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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.
Jonathan W. Stewart, MD principal investigator
New York State Psychiatric Institute - Columbia University Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranylcypromine, Dextroamphetamine and Triiodothyronine in people with Major Depression, run by New York State Psychiatric Institute 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 4 inclusion and 10 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 27 Apr 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study is no longer funded.). Results are not available in the source record.
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?
Hamilton Depression Scale (HAM-D) (time frame: up to 10 mos.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296686, which also lists 1 linked publication.
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 27 Apr 2012.