A Study in Patients With Major Depressive Disorder

NCT03642964 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTC-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole

  All subjects will be assessed for dose limiting side effects such as nausea, vomiting and diarrhea.

  multiple over 8 weeks

Secondary Outcomes (5)

• Safety will be assessed by Incidence of Treatment-Emergent Adverse Events

  Multiple over 8 weeks

• The Montgomery-Åsberg Depression Rating Scale

  Multiple over 7 weeks

• Clinical Global Impression - Severity scale

  Multiple over 7 weeks

• Clinical Global Impression - Improvement scale

  at week 8 only

• Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron

  Multiple over 7 weeks

Study Arms (2)

treatment

EXPERIMENTAL

CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily

Drug: CTC-501

placebo

PLACEBO COMPARATOR

generic placebo tablets given orally twice daily

Drug: CTC-501

Interventions

CTC-501 DRUG

pramipexole IR, given with ondansetron

placebo; treatment

Eligibility Criteria

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

You may qualify if:

• \- Patient Population: Males and females with a diagnosis of major depressive disorder
• Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate eligibility of the study.
• Males and females aged 18 and 65 years inclusive.
• Meet DSM-V R criteria for major depression, single episode or recurrent episode, with or without melancholia and without psychotic features (296.21, 296.22, 296.23, 296.31, 296.32, or 296.33).
• Had a total score of \> 18 on the HAM-D (17-item version), and a score of \> 2 on the depressed mood item of the HAM-D at the screening visit and at the baseline visit.
• Patients who are currently not on any antidepressants or, Patients on antidepressants and agree to the appropriate washout period (certain antidepressants with prolonged effects (e.g., fluoxetine) may need longer than 2 weeks post-discontinuation to obtain relatively uncontaminated baseline evaluation).
• Agreed not to start psychotherapy or behavior therapy during the trial. Patients currently on these types of therapy for at least 3 months are eligible for the study and could continue to receive therapy during the trial.

You may not qualify if:

• Women who are pregnant, or lactating; or taking a low-estrogen "mini-pill" contraceptive.
• Individuals who are currently taking either study medication (pramipexole and/or ondansetron).
• Renal and hepatic dysfunction with:
• Total Bilirubin: \>1.5 x UNL
• AST: \>2.5 x UNL
• ALT: \>2.5 x UNL
• Serum Creatinine: \>1.5 x UNL
• Creatinine Clearance: \<30 mL/min (calculated by Cockcroft and Gault equation)
• Hypersensitivity to any component of either study medication.
• Lifetime history of hypomania/mania, psychotic disorder, dementia and borderline or antisocial personality disorders.
• History of a serious suicidal attempt in the past 12 months; presence of serious suicidal tendencies/potential; modified C-SSRS \>4.
• Positive urine screen for benzodiazepines, cocaine/cocaine metabolites, cannabinoids, amphetamines, barbiturates, and opiates or history of moderate or severe substance dependence (drugs or alcohol, DSM-V-R criteria) within the past 6 months of the screening visit.
• Non-responders to at least two trials of antidepressant treatment in the past. (Therapeutic dose for at least 6 weeks)
• Patients currently taking or have taken the following medications within the past 6 months.
• Centrally acting dopamine antagonists

Sponsors & Collaborators

• Chase Therapeutics Corporation: lead

Study Sites (1)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Mark Leibowitz, MD

  Collaborative Neuroscience Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 22, 2018
• Study Start: September 10, 2018
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)