NCT00296686

Brief Summary

This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

4.9 years

First QC Date

February 23, 2006

Last Update Submit

April 26, 2012

Conditions

Major Depression

Keywords

Major DepressionRefractory DepressionTranylcypromineDextroamphetamineTriiodothyronine

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale (HAM-D)

    up to 10 mos.

Secondary Outcomes (3)

  • Beck Depression Inventory (BDI)

    up to 10 mos.

  • Clinical Global Impression (CGI)

    up to 10 mos.

  • Patient Global Impression (PGI)

    up to 10 mos.

Study Arms (1)

tranylcypromine

EXPERIMENTAL

sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3

Drug: TranylcypromineDrug: DextroamphetamineDrug: Triiodothyronine

Interventions

TranylcypromineDRUG

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.

Also known as: Parnate
tranylcypromine
DextroamphetamineDRUG

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.

Also known as: Dexedrine
tranylcypromine
TriiodothyronineDRUG

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).

Also known as: Cytomel
tranylcypromine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known Tranylcypromine allergy
  • Unable to follow tyramine-free diet
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Evaluation Service - New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 24972362DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-Resistant

Interventions

TranylcypromineDextroamphetamineTriiodothyronine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsAmphetamineAmphetaminesPhenethylaminesEthylaminesThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jonathan W. Stewart, MD

    New York State Psychiatric Institute - Columbia University Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

September 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(1)