Treatment-Resistant DepressionPhase 2NCT03312894
Efficacy and Safety of TAK-653 in Treatment-Resistant Depression
A Phase 2 study testing TAK-653 in people with Treatment-Resistant Depression, run by Millennium Pharmaceuticals, Inc..
Trial summary
The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-Resistant Depression
- What is being tested?
- TAK-653
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2018to 30 Sep 2019
- 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
- Has a primary diagnosis of major depressive disorder (MDD), without psychotic features, according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria, as assessed by a board-certified psychiatrist. MDD should be the principal diagnosis and the condition that best accounts for the clinical presentation. Participants with a secondary diagnosis of generalized anxiety disorder or social anxiety disorder may be included if, in the principal investigator's judgment, such diagnosis will not interfere with participation in the study or with outcome assessments. The diagnostic assessment must include a face-to-face evaluation of the participant using the Mini International Neuropsychiatric Interview (MINI).
- Has MDD that is resistant to treatment (i.e., TRD), defined as failure to respond to at least 2, but not more than 5, adequate trials of pharmacological treatment in the current episode, as determined using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH ATRQ).
- Qualifies as a candidate for receiving ketamine infusions as a treatment for their depression, in the opinion of the investigator.
- Is naive to ketamine treatment.
- Has a Hamilton Depression Rating Scale-17 (HAMD-17) total score of ≥22 at Screening.
- Is on stable pharmacological treatment for depression (≤50% change in dose) during the last 6 weeks prior to Randomization. Participants who are not currently taking pharmacological treatment for depression may be eligible, with the approval of the medical monitor.
Who cannot join
- The participant or any immediate family member has a seizure disorder or a history of seizure disorder, except febrile convulsions.
- Is currently diagnosed with a personality disorder, dementia, eating disorder, schizophrenia, schizoaffective disorder, or bipolar disorder.
- Has a history of neurological abnormalities that is judged by the medical monitor to preclude the participant's participation in the study; or brain injury including traumatic injury, perinatal encephalopathy, and postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma.
- Has a history of cerebral arteriosclerosis.
- Is currently diagnosed with glaucoma.
- Is at an imminent risk of suicide per the Columbia - Suicide Severity Rating Scale (C-SSRS) (score of 5) or per the investigator's clinical judgment.
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- Has uncontrolled hypertension or a systolic blood pressure of >150 millimeter of mercury (mm Hg) or diastolic blood pressure >95 mm Hg at Screening.
- Has a positive urine test result for drugs of abuse (defined as any illicit drug use) at Screening or Day 1.
- Has a blood alcohol content of ≥0.06% at Screening, prior to ketamine infusion (Day -5 or Day -1), or Day 1.
- Is currently diagnosed with abuse of or dependence on alcohol or other drugs (except nicotine). The participant will be allowed to enroll if his/her drug and alcohol abuse/dependence is in full (complete, not partial) sustained (>1 year) remission.
- Has any contraindication to the administration of ketamine.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-653 in the Treatment of Subjects With Treatment-Resistant Depression
The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms.
Read the detailed description
The drug being tested in this study is called TAK-653. TAK-653 is being tested to treat people who have depression and have not responded to several treatments (treatment-resistant depression).
This study will look at the efficacy and safety of TAK-653 in participants with treatment-resistant depression who take TAK-653 in addition to standard care.
The study will enroll approximately 90 patients. Participants who meet the study entry criteria will be assessed for response to ketamine by administering 2 intravenous (IV) infusions of ketamine (0.5 mg/kg given over 40 minutes; maximum dose 40 mg/day) on Day -5 (±1) and Day -1 (±1). To determine response to ketamine, the Day -5 predose Montgomery Åsberg Depression Rating Scale (MADRS) total score (before the first ketamine infusion) will be compared with the MADRS total score predose on Day 1 (24 hours after the second ketamine infusion on Day -1). Two cohorts (ketamine responders and ketamine nonresponders) of participants will be enrolled in parallel into the study.
Participants will then be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups - which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-653
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one tablet at the same time each day throughout the study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 78 days. Participants will make multiple visits to the clinic, and will be contacted by telephone on Day 78 after last dose of study drug for a follow-up assessment.
- Conditions
- Treatment-Resistant Depression
- Being tested
- TAK-653, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-653Drug
TAK-653 tablets
PlaceboDrug
Placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Ketamine Responders): TAK-653 6 mg | Experimental | TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 1 and 2; followed by TAK-653 tablets, orally, once daily on Days 3 and 4; followed by TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 5 to 7; followed by TAK-653 tablets, orally, once daily on Days 8 to 56. Receives: Drug: TAK-653; Drug: Placebo |
| Cohort 1 (Ketamine Responders): Placebo | Placebo comparator | TAK-653 placebo-matching tablets, orally, once daily up to Day 56 Receives: Drug: Placebo |
| Cohort 2 (Ketamine Nonresponders): TAK-653 6 mg | Experimental | TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 1 and 2; followed by TAK-653 tablets, orally, once daily on Days 3 and 4; followed by TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 5 to 7; followed by TAK-653 tablets, orally, once daily on Days 8 to 56. Receives: Drug: TAK-653; Drug: Placebo |
| Cohort 2 (Ketamine Nonresponders): Placebo | Placebo comparator | TAK-653 Placebo-matching tablets, orally, once daily up to Day 56 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Time to Relapse of Depressive Symptoms Postdose as Measured by Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms. Items are rated on scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: Baseline up to Day 57
Secondary outcomes (8)
Cohort 1: Change from Baseline in MADRS Total Score at the End of Each Week of Treatment
The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms. Items are rated on scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: Baseline and weekly up to Day 57
Cohort 1: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at the End of Each Week of Treatment
The CGI-S is a 7-point global assessment that measures the clinician's impression of the severity of a participant's illness. It takes into account all available information, such as patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. A rating of 1 corresponds to "Normal, not at all ill" and a rating of 7 corresponds to "Among the most extremely ill participants." Higher scores indicate more severe illness.
Measured: Baseline and weekly up to Day 57
Cohort 1: Change From Baseline in Quick Inventory of Depressive Symptomatology-16 Item (QIDS-SR16) Total Score at the End of Each Week of Treatment
The QIDS-SR16 is a 16-item self-report measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology (IDS). The QIDS-SR16 assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV), to diagnose a major depressive episode. QIDS-SR16 assessment has been used to screen for depression and also to measure symptom severity. This scale is also used to distinguish response from remission, as well as to quantify between group treatments effects in open label and randomized controlled trials. The participant is asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27.
Measured: Baseline and weekly up to Day 57
Cohort 1: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Baseline up to Day 78
Cohort 1: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) that Led to Study Drug Discontinuation
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Signs Measurement at Least Once Postdose
Vital signs will include body temperature (oral measurement), supine blood pressure (after the participant has rested for at least 5 minutes), respiration rate, and pulse (beats per minute [bpm]).
Measured: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose
The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout the study. Safety Laboratory tests include serum chemistry, hematology and urinalysis.
Measured: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose
The percentage of participants who meet markedly abnormal criteria as measured by a standard 12-lead ECG throughout the study.
Measured: Baseline up to Day 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start15 Feb 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312894
- Sponsor's protocol ID
- TAK-653-2001
- Other IDs
- 2017-002232-16, U1111-1200-8817, 17/SC/0606, FAGG/R&D/LFT, 2017
- Status last verified
- Feb 2018
- First submitted
- 13 Oct 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-653 in the Treatment of Subjects With Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT03312894
- Acronym / sponsor ID
- TAK-653-2001
- Conditions
- Treatment-Resistant Depression
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 18 Oct 2017 (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.
The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms.
Detailed description
The drug being tested in this study is called TAK-653. TAK-653 is being tested to treat people who have depression and have not responded to several treatments (treatment-resistant depression).
This study will look at the efficacy and safety of TAK-653 in participants with treatment-resistant depression who take TAK-653 in addition to standard care.
The study will enroll approximately 90 patients. Participants who meet the study entry criteria will be assessed for response to ketamine by administering 2 intravenous (IV) infusions of ketamine (0.5 mg/kg given over 40 minutes; maximum dose 40 mg/day) on Day -5 (±1) and Day -1 (±1). To determine response to ketamine, the Day -5 predose Montgomery Åsberg Depression Rating Scale (MADRS) total score (before the first ketamine infusion) will be compared with the MADRS total score predose on Day 1 (24 hours after the second ketamine infusion on Day -1). Two cohorts (ketamine responders and ketamine nonresponders) of participants will be enrolled in parallel into the study.
Participants will then be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups - which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-653
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one tablet at the same time each day throughout the study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 78 days. Participants will make multiple visits to the clinic, and will be contacted by telephone on Day 78 after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Ketamine Responders): TAK-653 6 mg | Experimental | Drug: TAK-653, Drug: PlaceboTAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 1 and 2; followed by TAK-653 tablets, orally, once daily on Days 3 and 4; followed by TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 5 to 7; followed by TAK-653 tablets, orally, once daily on Days 8 to 56. |
| Cohort 1 (Ketamine Responders): Placebo | Placebo comparator | Drug: PlaceboTAK-653 placebo-matching tablets, orally, once daily up to Day 56 |
| Cohort 2 (Ketamine Nonresponders): TAK-653 6 mg | Experimental | Drug: TAK-653, Drug: PlaceboTAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 1 and 2; followed by TAK-653 tablets, orally, once daily on Days 3 and 4; followed by TAK-653 tablets plus TAK-653 placebo-matching tablets, orally, once daily on Days 5 to 7; followed by TAK-653 tablets, orally, once daily on Days 8 to 56. |
| Cohort 2 (Ketamine Nonresponders): Placebo | Placebo comparator | Drug: PlaceboTAK-653 Placebo-matching tablets, orally, once daily up to Day 56 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a primary diagnosis of major depressive disorder (MDD), without psychotic features, according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria, as assessed by a board-certified psychiatrist. MDD should be the principal diagnosis and the condition that best accounts for the clinical presentation. Participants with a secondary diagnosis of generalized anxiety disorder or social anxiety disorder may be included if, in the principal investigator's judgment, such diagnosis will not interfere with participation in the study or with outcome assessments. The diagnostic assessment must include a face-to-face evaluation of the participant using the Mini International Neuropsychiatric Interview (MINI).
- Has MDD that is resistant to treatment (i.e., TRD), defined as failure to respond to at least 2, but not more than 5, adequate trials of pharmacological treatment in the current episode, as determined using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH ATRQ).
- Qualifies as a candidate for receiving ketamine infusions as a treatment for their depression, in the opinion of the investigator.
- Is naive to ketamine treatment.
- Has a Hamilton Depression Rating Scale-17 (HAMD-17) total score of ≥22 at Screening.
Key exclusion criteria (11 listed)
- The participant or any immediate family member has a seizure disorder or a history of seizure disorder, except febrile convulsions.
- Is currently diagnosed with a personality disorder, dementia, eating disorder, schizophrenia, schizoaffective disorder, or bipolar disorder.
- Has a history of neurological abnormalities that is judged by the medical monitor to preclude the participant's participation in the study; or brain injury including traumatic injury, perinatal encephalopathy, and postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma.
- Has a history of cerebral arteriosclerosis.
- Is currently diagnosed with glaucoma.
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 |
|---|---|---|
| TAK-653TAK-653 tablets | Drug | Cohort 1 (Ketamine Responders): TAK-653 6 mg, Cohort 2 (Ketamine Nonresponders): TAK-653 6 mg |
| PlaceboPlacebo-matching tablets | Drug | Cohort 1 (Ketamine Responders): Placebo, Cohort 1 (Ketamine Responders): TAK-653 6 mg, Cohort 2 (Ketamine Nonresponders): Placebo, Cohort 2 (Ketamine Nonresponders): TAK-653 6 mg |
Primary outcome
Cohort 1: Time to Relapse of Depressive Symptoms Postdose as Measured by Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline up to Day 57
The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms. Items are rated on scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
8 secondary outcomes
Cohort 1: Change from Baseline in MADRS Total Score at the End of Each Week of Treatment
Time frame: Baseline and weekly up to Day 57
Cohort 1: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at the End of Each Week of Treatment
Time frame: Baseline and weekly up to Day 57
Cohort 1: Change From Baseline in Quick Inventory of Depressive Symptomatology-16 Item (QIDS-SR16) Total Score at the End of Each Week of Treatment
Time frame: Baseline and weekly up to Day 57
Cohort 1: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 78
Cohort 1: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) that Led to Study Drug Discontinuation
Time frame: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Signs Measurement at Least Once Postdose
Time frame: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose
Time frame: Baseline up to Day 78
Cohort 1: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose
Time frame: Baseline up to Day 78
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-653 in people with Treatment-Resistant Depression, run by Millennium Pharmaceuticals, Inc..
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cohort 1: Time to Relapse of Depressive Symptoms Postdose as Measured by Montgomery Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline up to Day 57). 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 22 Feb 2018.