A Study in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03642964|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder (MDD)||Drug: CTC-501||Phase 2|
This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).
Subjects will sign consent form prior to any study related procedure and will complete screening assessments. Subjects will be randomized to either the treatment group or the placebo group at a ratio of 1:1.
The study will be conducted in two parts. Titration period On Day 1, subjects will complete all baseline assessments prior to the 1st dosing.
Pramipexole group: Consenting individuals meeting accession criteria will start pramipexole 2.0mg daily dose (1.0mg twice a day) with ondansetron 16mg daily dose (8mg twice a day). Pramipexole will be titrated up daily or every two days depends on each patients' tolerability up to the first intolerable dose (FID) or maximum allowed dose (5 mg/day) according to titration schedule (Table 1). Once subjects reach their FID, their maximum allowed dose (MTD) will be defined as 1 mg below their FID.
During titration, subjects will be admitted to the clinic (subjects will be discharged on the day following their pramipexole FID or Day 8 if subjects reach to 5 mg/day of pramipexole.
Placebo group will take 3 placebo tablets twice a day. Maintenance period During the maintenance phase, patients will be treated with pramipexole MTD or MAD with ondansetron 16mg/day for the remainder of the 8-week treatment.
Placebo group is taking 3 tablets of placebo twice a day during the trial. Exit visit After the Week 8 visit, study medications will be discontinued, and subject will return for Exit visit at Week 9.
After the Exit visit, all subjects will return to their prior treatment for depression or started on a new therapeutic regimen as medically appropriate.
At study completion (or at other times in accordance with Stopping Rules given below), and all study participants will return to their pre-admission therapeutic regimen or started on a new therapeutic regimen as medically appropriate. Higher doses of pramipexole IR may be tapered off at rates deemed medically appropriate by PI.
In this modified single blind study, efficacy raters will be kept unaware of the participants' treatment status.
An independent data and safety monitoring board (DSMB) will be appointed to have responsibility for safeguarding the interests of the trial subjects and assessing the safety and tolerability of the study treatments during the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Phase 2a Study to Evaluate the Safety, Tolerability and Initial Efficacy of Pramipexole IR, Given With Ondansetron in Patients With Major Depressive Disorder|
|Actual Study Start Date :||September 10, 2018|
|Estimated Primary Completion Date :||January 30, 2019|
|Estimated Study Completion Date :||January 30, 2019|
CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily
pramipexole IR, given with ondansetron
Placebo Comparator: placebo
generic placebo tablets given orally twice daily
pramipexole IR, given with ondansetron
- Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole [ Time Frame: multiple over 8 weeks ]All subjects will be assessed for dose limiting side effects such as nausea, vomiting and diarrhea.
- Safety will be assessed by Incidence of Treatment-Emergent Adverse Events [ Time Frame: Multiple over 8 weeks ]Incidence and nature of adverse events; vital signs; weight ; physical examination changes; clinical laboratory evaluations; ECG.
- The Montgomery-Åsberg Depression Rating Scale [ Time Frame: Multiple over 7 weeks ]Change from baseline in the following depression scale; The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorder. Mean change from baseline on the Montgomery Asberg Depression Rating Scale. (MADRS) Relative to Standard of Care. The MADRS is a 10 item scale with each item scored from 0 to 6 where 0 represents minimal symptoms and 6 represents maximum response to that item. The total MADRS score ranges from 0 to 60.
- Clinical Global Impression - Severity scale [ Time Frame: Multiple over 7 weeks ]
Change from baseline in the following depression scales.Mean change from baseline on the CGI-Severity of Illness(CGI-SI) score overtime.The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
o CGI-Global Improvement (CGI-GI) score at the end of 8-week maintenance period
- Clinical Global Impression - Improvement scale [ Time Frame: at week 8 only ]Change from baseline in the following depression scales;The Clinical Global Improvement - CGI-Global Improvement (CGI-GI) score at the end of 8-week maintenance period is a one question scale comparing who the clinician feels the patient's condition has changed from baseline. The scale is from 0-7 (0 being 'not assessed' to 7 being 'very much worse'.
- Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron [ Time Frame: Multiple over 7 weeks ]Plasma concentrations of pramipexole and ondansetron will be measured at various times throughout the study in only pramipexole group. Both groups will have blood draws.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642964
|United States, California|
|Collaborative Neuroscience Network|
|Long Beach, California, United States, 90806|
|Principal Investigator:||Mark Leibowitz, MD||Collaborative Neuroscience Network|