Clinical Trial Results:
A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3-week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression
Summary
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EudraCT number |
2021-004927-34 |
Trial protocol |
DE CZ PL |
Global end of trial date |
10 May 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
24 May 2024
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First version publication date |
24 May 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
KET01-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ketabon GmbH
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Sponsor organisation address |
Wilhelm-Wagenfeld-Straße 20, München, Germany, 80807
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Public contact |
Hans Eriksson, MD, PhD, MBA, Sponsor’s Medical Expert, 0049 15172515268, hans.eriksson@hmnc-brainhealth.com
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Scientific contact |
Hans Eriksson, MD, PhD, MBA, Sponsor’s Medical Expert, 0049 15172515268, hans.eriksson@hmnc-brainhealth.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Jun 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Apr 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
10 May 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To explore the efficacy of KET01 (120 mg or 240 mg) administered once daily (OD) as add-on therapy to standard treatment compared to placebo with respect to improvement of depressive symptoms assessed by change in Montgomery–Åsberg Depression Rating Scale (MADRS) total score in subjects with major depressive disorder (MDD), fulfilling criteria for treatment-resistant depression (TRD).
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Protection of trial subjects |
This trial was performed in compliance with Good Clinical Practices (GCP) and applicable regulatory requirements, including the archiving of essential documents.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 May 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 53
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Country: Number of subjects enrolled |
Czechia: 52
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Country: Number of subjects enrolled |
Poland: 62
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Worldwide total number of subjects |
167
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EEA total number of subjects |
167
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
166
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
This exploratory trial was performed from May 2022 to May 2023 at 29 sites in Czech Republic, Germany and Poland. 167 subjects enrolled in the trial | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects who met all the inclusion criteria and none of the exclusion criteria. Of the 167 subjects enrolled in the trial, 45 were screening failures and 122 were kept to be randomised to receive either KET01 240 mg, KET01 120 mg or placebo at Treatment Period - Visit 2b. | ||||||||||||||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
167 | ||||||||||||||||||||||||||||||||||||
Number of subjects completed |
122 | ||||||||||||||||||||||||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Adverse event, non-fatal: 1 | ||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Consent withdrawn by subject: 1 | ||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Ineligibility/development of 1/mult. excl. crit.: 42 | ||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Lost to follow-up: 1 | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Baseline - Visit 2a
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||
Blinding implementation details |
At this visit, where baseline values are evaluated, there was still no allocation to treatment done. This period and it arms are defined due to technical issues since validator expects a postassignment period marked for baseline and expects definition of arms for a postassignment period.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Baseline - KET01-240 | ||||||||||||||||||||||||||||||||||||
Arm description |
Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
None
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Not assigned
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Routes of administration |
Not mentioned
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Dosage and administration details |
Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period
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Arm title
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Baseline - KET01-120 | ||||||||||||||||||||||||||||||||||||
Arm description |
Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
None
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Not assigned
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Routes of administration |
Not mentioned
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Dosage and administration details |
Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period
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Arm title
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Baseline - Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Not assigned
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Routes of administration |
Not mentioned
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Dosage and administration details |
Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Number of subjects in the baseline period are defined as subjects who met all the inclusion criteria and none of the exclusion criteria. Of the 167 subjects enrolled in the trial, 45 were screening failures and 122 were kept to be randomised to receive either KET01 240 mg, KET01 120 mg or placebo at Treatment Period. |
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Period 2
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Period 2 title |
Treatment
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment - KET01-240 | ||||||||||||||||||||||||||||||||||||
Arm description |
KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ketamine hydrochloride (HCl)
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Investigational medicinal product code |
KET01
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 240 mg ketamine hydrochloride by 2 KET01 tablets 40 mg (pink) and 2 KET01 tablets 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received 240 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Arm title
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Treatment - KET01-120 | ||||||||||||||||||||||||||||||||||||
Arm description |
KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ketamine hydrochloride (HCl)
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Investigational medicinal product code |
KET01
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 120 mg ketamine hydrochloride by 1 KET01 tablet 40 mg (pink), 1 KET01 tablet 80 mg (white), 1 Placebo tablet1 40 mg (pink) and 1 Placebo tablet 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received 120 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Arm title
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Treatment - Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 0 mg ketamine hydrochloride by 2 Placebo tablets 40 mg (pink) and 2 Placebo tablets 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received placebo as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Period 3
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Period 3 title |
Follow-up
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Follow-up - KET01-240 | ||||||||||||||||||||||||||||||||||||
Arm description |
KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ketamine hydrochloride (HCl)
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Investigational medicinal product code |
KET01
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 240 mg ketamine hydrochloride by 2 KET01 tablets 40 mg (pink) and 2 KET01 tablets 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received 240 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Arm title
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Follow-up - KET01-120 | ||||||||||||||||||||||||||||||||||||
Arm description |
KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ketamine hydrochloride (HCl)
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Investigational medicinal product code |
KET01
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 120 mg ketamine hydrochloride by 1 KET01 tablet 40 mg (pink), 1 KET01 tablet 80 mg (white), 1 Placebo tablet 40 mg (pink) and 1 Placebo tablet 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received 120 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Arm title
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Follow-up - Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration.
Subjects took a total daily dose of 0 mg ketamine hydrochloride by 2 Placebo tablets 40 mg (pink) and 2 Placebo tablets 80 mg (white). Dose was taken once daily in the morning.
Duration of treatment:
Subjects received placebo as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b.
Subjects had to take 4 tablets, once daily in the morning together with a glass of water.
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Notes [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: In total not only the subjects that completed the previous period but all 122 subjects started in the treatment period should be followed up and should complete a Follow-Up visit to document the development of score . In total 121 of 122 subjects did the Follow-Up visit. Due to technical issues only the 112 of 113 subjects, that completed the previous period and had a follow-up visit, could be stated here instead the 121 participating subjects. |
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Baseline characteristics reporting groups
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Reporting group title |
Baseline - KET01-240
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Baseline - KET01-120
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Baseline - Placebo
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline - KET01-240
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period | ||
Reporting group title |
Baseline - KET01-120
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period | ||
Reporting group title |
Baseline - Placebo
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Reporting group description |
Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period | ||
Reporting group title |
Treatment - KET01-240
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Reporting group description |
KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Reporting group title |
Treatment - KET01-120
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Reporting group description |
KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Reporting group title |
Treatment - Placebo
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Reporting group description |
Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Reporting group title |
Follow-up - KET01-240
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Reporting group description |
KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Reporting group title |
Follow-up - KET01-120
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Reporting group description |
KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Reporting group title |
Follow-up - Placebo
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Reporting group description |
Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial | ||
Subject analysis set title |
Treatment - KET01-240 x Safety Set
|
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety set (SAF) was defined as all subjects who received at least one dose of IP.
|
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Subject analysis set title |
Treatment - KET01-120 x Safety Set
|
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety set (SAF) was defined as all subjects who received at least one dose of IP.
|
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Subject analysis set title |
Treatment - Placebo x Safety Set
|
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety set (SAF) was defined as all subjects who received at least one dose of IP.
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Subject analysis set title |
Treatment - KET01-240 x Full Analysis Set
|
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.
|
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Subject analysis set title |
Treatment - KET01-120 x Full Analysis Set
|
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.
|
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Subject analysis set title |
Treatment - Placebo x Full Analysis Set
|
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.
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Subject analysis set title |
Treatment - KET01-240 x Per Protocol Set
|
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.
|
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Subject analysis set title |
Treatment - KET01-120 x Per Protocol Set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.
|
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Subject analysis set title |
Treatment - Placebo x Per Protocol Set
|
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.
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End point title |
Change in MADRS total score | ||||||||||||||||||||
End point description |
Change from baseline at Visit 2a to Visit 6 / early discontinuation visit (EDV) in MADRS total score.
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End point type |
Primary
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End point timeframe |
3 weeks
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Statistical analysis title |
MMRM, Full analysis set. | ||||||||||||||||||||
Statistical analysis description |
mixed model for repeated measures (MMRM) with fixed effects of treatment, visit, visit and treatment interaction and baseline MADRS total score as a covariate as well as random effects of subject and country
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Comparison groups |
Treatment - KET01-240 x Full Analysis Set v Treatment - Placebo x Full Analysis Set
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Number of subjects included in analysis |
80
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.4125 | ||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||
Parameter type |
LS Mean Difference | ||||||||||||||||||||
Point estimate |
-1.82
|
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
|
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lower limit |
-6.21 | ||||||||||||||||||||
upper limit |
2.57 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
2.215
|
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Statistical analysis title |
MMRM, Full analysis set. | ||||||||||||||||||||
Statistical analysis description |
mixed model for repeated measures (MMRM) with fixed effects of treatment, visit, visit and treatment interaction and baseline MADRS total score as a covariate as well as random effects of subject and country
|
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Comparison groups |
Treatment - KET01-120 x Full Analysis Set v Treatment - Placebo x Full Analysis Set
|
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Number of subjects included in analysis |
82
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.8516 | ||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||
Parameter type |
LS Mean Difference | ||||||||||||||||||||
Point estimate |
-0.41
|
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Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
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lower limit |
-4.75 | ||||||||||||||||||||
upper limit |
3.93 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
2.19
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Adverse events information
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Timeframe for reporting adverse events |
AEs with the first onset or worsening after the first IP intake and not more than 14 days after the last IP intake were defined as TEAEs in this trial, the period of observation for the collection of AEs extends from informed consent given til final visit
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Adverse event reporting additional description |
Only numbers of TEAEs are reported. Frequency threshold for reporting non-serious adverse event was set to 4%.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
Treatment - KET01-240 x Safety Set
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Reporting group description |
Subjects in the Safety Set treated with KET01 240 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment - Placebo x Safety Set
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Reporting group description |
Subjects in the Safety Set treated with Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment - KET01-120 x Safety Set
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Reporting group description |
Subjects in the Safety Set treated with KET01 120 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |