Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response, Pilot Trial

NCT03367533

Depressive Disorder, Major Post Traumatic Stress Disorder Bipolar Disorder

COMPLETED PHASE1

Tianeptine for Treatment Resistant Depression

NCT04249596

Treatment Resistant Depression

TERMINATED PHASE4

Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

NCT02660528

Major Depressive Disorder

TERMINATED PHASE2

SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

NCT01435759

Major Depressive Disorder

COMPLETED PHASE2

Investigating the Protective Impact of LY-2940094 on Stress-induced Depression- and Anxiety-related Phenotypes in Humans

NCT06786637

Depression - Major Depressive Disorder Anxiety Stress

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tranylcypromine

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

Group Type EXPERIMENTAL

Tranylcypromine

Intervention Type DRUG

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.

Dextroamphetamine

Intervention Type DRUG

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.

Triiodothyronine

Intervention Type DRUG

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranylcypromine

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.

Intervention Type DRUG

Dextroamphetamine

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.

Intervention Type DRUG

Triiodothyronine

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).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Parnate Dexedrine Cytomel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No