Major Depressive Disorder (MDD)Phase 2NCT03642964
A Study in Patients With Major Depressive Disorder
A Phase 2 study testing CTC-501 in people with Major Depressive Disorder (MDD), run by Chase Therapeutics Corporation at 1 site in United States.
Trial summary
This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- CTC-501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 30 Dec 2025
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
- MAOI
- Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- Patients who have clinical significant hypotension or any clinical significant ECG abnormality at screening.
- Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- Patients who have participated in another clinical trial with an investigational drug within previous 30 days or 5 half-lives whichever is longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Network
Long Beach, California, 90806
About this study
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
This is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).
Read the detailed description
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- CTC-501
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC-501Drug
pramipexole IR, given with ondansetron
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily Receives: Drug: CTC-501 |
| placebo | Placebo comparator | generic placebo tablets given orally twice daily Receives: Drug: CTC-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: multiple over 8 weeks
Secondary outcomes (5)
Safety will be assessed by Incidence of Treatment-Emergent Adverse Events
Incidence and nature of adverse events; vital signs; weight ; physical examination changes; clinical laboratory evaluations; ECG.
Measured: Multiple over 8 weeks
The Montgomery-Åsberg Depression Rating Scale
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.
Measured: Multiple over 7 weeks
Clinical Global Impression - Severity scale
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.
- CGI-Global Improvement (CGI-GI) score at the end of 8-week maintenance period
Measured: Multiple over 7 weeks
Clinical Global Impression - Improvement scale
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'.
Measured: at week 8 only
Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron
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.
Measured: Multiple over 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start10 Sep 2018
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chase Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Leibowitz, MD, Principal investigator, Collaborative Neuroscience Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642964
- Sponsor's protocol ID
- CTC-003
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2018
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03642964
- Acronym / sponsor ID
- CTC-003
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chase Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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 is a Phase 2a, placebo-controlled, single-blind study in up to 24 patients with major depressive disorder (MDD).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: CTC-501CTC-501 (pramipexole IR, given with ondansetron) given orally twice daily |
| placebo | Placebo comparator | Drug: CTC-501generic placebo tablets given orally twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- Hypersensitivity to any component of either study medication.
- Lifetime history of hypomania/mania, psychotic disorder, dementia and borderline or antisocial personality disorders.
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 |
|---|---|---|
| CTC-501pramipexole IR, given with ondansetron | Drug | placebo, treatment |
Primary outcome
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.
5 secondary outcomes
Safety will be assessed by Incidence of Treatment-Emergent Adverse Events
Time frame: Multiple over 8 weeks
The Montgomery-Åsberg Depression Rating Scale
Time frame: Multiple over 7 weeks
Clinical Global Impression - Severity scale
Time frame: Multiple over 7 weeks
Clinical Global Impression - Improvement scale
Time frame: at week 8 only
Pharmacokinetics will measure plasma concentrations of pramipexole and ondansetron
Time frame: Multiple over 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No. At this time there is no plan to share IPD.
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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.
Mark Leibowitz, MD principal investigator
Collaborative Neuroscience Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTC-501 in people with Major Depressive Disorder (MDD), run by Chase Therapeutics Corporation 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Tolerability will be assessed by the determination of a Maximum Tolerated Dose of pramipexole (time frame: multiple over 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.