Trial Outcomes & Findings for A Phase 2 Trial of OPC-64005 for Major Depressive Disorder (NCT NCT04244253)

NCT ID: NCT04244253

Last Updated: 2024-09-19

Results Overview

The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition. 1\. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 273 participants
• Primary outcome timeframe: Baseline, Week 1, 2, 3, 4, 5, and 6
• Results posted on: 2024-09-19

Participant Flow

This trial was conducted in 273 subjects from 69 trial sites in Japan.

Adult subjects with Major Depressive Disorder defined by criteria of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).

Participant milestones

Measure	OPC-64005 10-mg One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo Two placebo tablets administered orally once daily for 6 weeks
Overall Study STARTED	31	121	121
Overall Study COMPLETED	28	116	109
Overall Study NOT COMPLETED	3	5	12

Reasons for withdrawal

Measure	OPC-64005 10-mg One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo Two placebo tablets administered orally once daily for 6 weeks
Overall Study Adverse Event	2	2	4
Overall Study Protocol Violation	1	2	1
Overall Study Withdrawal by Subject	0	1	6
Overall Study Non-Compliance With Study Drug	0	0	1

Baseline Characteristics

A Phase 2 Trial of OPC-64005 for Major Depressive Disorder

Baseline characteristics by cohort

Measure	OPC-64005 10-mg n=31 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=121 Participants Two placebo tablets administered orally once daily for 6 weeks	Total n=273 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	121 Participants n=7 Participants	121 Participants n=5 Participants	273 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	39.5 years STANDARD_DEVIATION 11.4 • n=7 Participants	38.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	38.8 years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	56 Participants n=7 Participants	58 Participants n=5 Participants	131 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	65 Participants n=7 Participants	63 Participants n=5 Participants	142 Participants n=4 Participants
Race/Ethnicity, Customized Asian	31 Participants n=5 Participants	121 Participants n=7 Participants	121 Participants n=5 Participants	273 Participants n=4 Participants
Region of Enrollment Japan	31 participants n=5 Participants	121 participants n=7 Participants	121 participants n=5 Participants	273 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, and 6

Population: The full analysis set (FAS) includes all subjects who were administered at least 1 dose of double-blind IMP and have MADRS total scores at baseline and at least one time point after the start of double-blind treatment. FAS excluded one subject in the placebo group for whom no MADRS total score was obtained after start of double-blind treatment.

The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition.

1. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts

Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition.

Outcome measures

Measure	OPC-64005 10-mg n=31 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=120 Participants Two placebo tablets administered orally once daily for 6 weeks
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 1Week	-1.9 Units on a scale Standard Error 0.8	-1.6 Units on a scale Standard Error 0.4	-2.1 Units on a scale Standard Error 0.4
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 2Week	-3.9 Units on a scale Standard Error 1.0	-3.4 Units on a scale Standard Error 0.5	-3.6 Units on a scale Standard Error 0.5
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 3Week	-7.1 Units on a scale Standard Error 1.2	-5.7 Units on a scale Standard Error 0.6	-5.2 Units on a scale Standard Error 0.6
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 4Week	-9.5 Units on a scale Standard Error 1.3	-7.5 Units on a scale Standard Error 0.7	-6.3 Units on a scale Standard Error 0.7
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 5Week	-10.6 Units on a scale Standard Error 1.4	-8.9 Units on a scale Standard Error 0.7	-8.1 Units on a scale Standard Error 0.7
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period 6Week	-11.2 Units on a scale Standard Error 1.5	-10.7 Units on a scale Standard Error 0.8	-9.5 Units on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, and 6

Population: The full analysis set (FAS) included all subjects who were administered at least 1 dose of double-blind IMP and had MADRS total scores at baseline and at least one time point after the start of double-blind treatment.

The MADRS response rate is the percentage of subjects with ≥50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period.

Outcome measures

Measure	OPC-64005 10-mg n=31 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=120 Participants Two placebo tablets administered orally once daily for 6 weeks
MADRS Response Rate 1Week	0.0 percentage of participants	0.8 percentage of participants	0.8 percentage of participants
MADRS Response Rate 2Week	3.2 percentage of participants	5.0 percentage of participants	3.3 percentage of participants
MADRS Response Rate 3Week	12.9 percentage of participants	9.9 percentage of participants	6.7 percentage of participants
MADRS Response Rate 4Week	22.6 percentage of participants	14.9 percentage of participants	10.0 percentage of participants
MADRS Response Rate 5Week	25.8 percentage of participants	18.2 percentage of participants	18.3 percentage of participants
MADRS Response Rate 6Week	32.3 percentage of participants	29.8 percentage of participants	24.2 percentage of participants

SECONDARY outcome

Timeframe: Week6

Population: The full analysis set (FAS) included all subjects who were administered at least 1 dose of double-blind IMP and had MADRS total scores at baseline and at least one time point after the start of double-blind treatment.

MADRS remission rate is the percentage of subjects with MADRS total score ≤ 10 and ≥ 50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period.

Outcome measures

Measure	OPC-64005 10-mg n=31 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 Participants One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=120 Participants Two placebo tablets administered orally once daily for 6 weeks
MADRS Remission Rate	16.1 percentage of participants	14.9 percentage of participants	13.3 percentage of participants

Adverse Events

OPC-64005 10-mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

OPC-64005 20-mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	OPC-64005 10-mg n=31 participants at risk One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 participants at risk One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=121 participants at risk Two placebo tablets administered orally once daily for 6 weeks
Infections and infestations Appendicitis	0.00% 0/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.83% 1/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.00% 0/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Psychiatric disorders Major depression	0.00% 0/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.83% 1/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.00% 0/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Psychiatric disorders Suicidal ideation	0.00% 0/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.00% 0/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.83% 1/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.

Other adverse events

Measure	OPC-64005 10-mg n=31 participants at risk One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 6 weeks	OPC-64005 20-mg n=121 participants at risk One placebo tablet and one OPC-64005 10-mg tablet administered orally once daily for 1 week, followed by two OPC-64005 10-mg tablets for 5 weeks	Placebo n=121 participants at risk Two placebo tablets administered orally once daily for 6 weeks
Nervous system disorders Headache	6.5% 2/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	5.0% 6/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	2.5% 3/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Psychiatric disorders Insomnia	0.00% 0/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	6.6% 8/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	3.3% 4/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Gastrointestinal disorders Nausea	0.00% 0/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	5.8% 7/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	7.4% 9/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Infections and infestations Nasopharyngitis	9.7% 3/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.00% 0/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	5.8% 7/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.
Skin and subcutaneous tissue disorders Rash	6.5% 2/31 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.83% 1/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.	0.00% 0/121 • Adverse events were monitored from the date of signed informed consent until 14 (±7) days during the post treatment observation period after the last IMP administration. An AE is defined as any untoward medical occurrence in a patient or clinical trial subject administered an IMP and which does not necessarily have a causal relationship with this treatment.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: CL_OPCJ_RDA_Team@otsuka.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place