Major Depressive DisorderPhase 2NCT04244253

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

A Phase 2 study testing OPC-64005 20 mg , Once-daily and OPC-64005 10 mg , Once-daily in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)… Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: OPC-64005 20 mg , Once-daily and OPC-64005 10 mg , Once-daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 273 participants
Where: 1 siteJapan
Study dates: 3 Mar 2020to 25 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" with the current episode persisting for ≥4 weeks to ≤1 year
Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)

Who cannot join

Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent)
Patients exhibiting mood-incongruent psychotic features in the current major depressive episode
Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode
Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Medical Corporation Jisenkai Himorogi Psychiatric Institute
Tokyo

Other trials in Japan

About this study

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: OPC-64005 20 mg , Once-daily, OPC-64005 10 mg , Once-daily, Placebo, Once-daily
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.

OPC-64005 20 mg , Once-dailyDrug
Active, High Dose
OPC-64005 10 mg , Once-dailyDrug
Active, Low Dose
Placebo, Once-dailyDrug
Placebo

Study groups in NCT04244253
Study group	Role	What they receive
OPC-64005 20 mg	Experimental	Not described Receives: Drug: OPC-64005 20 mg , Once-daily
OPC-64005 10 mg	Experimental	Not described Receives: Drug: OPC-64005 10 mg , Once-daily
Placebo	Placebo comparator	Not described Receives: Drug: Placebo, Once-daily

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period
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.
Measured: Baseline, Week 1, 2, 3, 4, 5, and 6

Secondary outcomes (2)

MADRS Response Rate
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.
Measured: Baseline, Week 1, 2, 3, 4, 5, and 6
MADRS Remission Rate
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.
Measured: Week6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202025 Feb 2022

First posted28 Jan 2020
Study start3 Mar 2020
Primary completion8 Feb 2022
Study completion25 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04244253
Sponsor's protocol ID: 277-102-00027
Other IDs: JapicCTI-205116
Status last verified: May 2024
First submitted: 23 Jan 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT04244253
Acronym / sponsor ID: 277-102-00027
Conditions: Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Mar 2020 (actual)
Primary completion: 8 Feb 2022 (actual)
Study completion: 25 Feb 2022 (actual)
First posted: 28 Jan 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
OPC-64005 20 mg	Experimental	Drug: OPC-64005 20 mg , Once-daily
OPC-64005 10 mg	Experimental	Drug: OPC-64005 10 mg , Once-daily
Placebo	Placebo comparator	Drug: Placebo, Once-daily

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" with the current episode persisting for ≥4 weeks to ≤1 year
Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)

Key exclusion criteria (4 listed)

Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent)
Patients exhibiting mood-incongruent psychotic features in the current major depressive episode
Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode
Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)

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
OPC-64005 20 mg , Once-dailyActive, High Dose	Drug	OPC-64005 20 mg
OPC-64005 10 mg , Once-dailyActive, Low Dose	Drug	OPC-64005 10 mg
Placebo, Once-dailyPlacebo	Drug	Placebo

Primary outcome

Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period
Time frame: Baseline, Week 1, 2, 3, 4, 5, and 6
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.

2 secondary outcomes

MADRS Response Rate
Time frame: Baseline, Week 1, 2, 3, 4, 5, and 6
MADRS Remission Rate
Time frame: Week6

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OPC-64005 10-mg	31	28
OPC-64005 20-mg	121	116
Placebo	121	109

Primary outcome: Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period

Time frame: Baseline, Week 1, 2, 3, 4, 5, and 6. Mean (Standard Error). Unit: Units on a scale

Measure	OPC-64005 10-mg n = 31	OPC-64005 20-mg n = 121	Placebo n = 120
1Week	-1.9 (0.8)	-1.6 (0.4)	-2.1 (0.4)
2Week	-3.9 (1.0)	-3.4 (0.5)	-3.6 (0.5)
3Week	-7.1 (1.2)	-5.7 (0.6)	-5.2 (0.6)
4Week	-9.5 (1.3)	-7.5 (0.7)	-6.3 (0.7)
5Week	-10.6 (1.4)	-8.9 (0.7)	-8.1 (0.7)
6Week	-11.2 (1.5)	-10.7 (0.8)	-9.5 (0.8)

OPC-64005 20-mg vs Placebo: Difference of score: -1.1 (95% CI -3.3 to 1.0), p = 0.288, Mixed-model repeated measures

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-64005 10-mg	0 of 31 (0%)	7 of 31 (22.6%)	0 of 31
OPC-64005 20-mg	2 of 121 (1.7%)	19 of 121 (15.7%)	0 of 121
Placebo	1 of 121 (0.8%)	19 of 121 (15.7%)	0 of 121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Related trials for Major Depressive Disorder

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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.

Takehisa Matsumaru study director

Otsuka Pharmaceutical Co., Ltd.

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 OPC-64005 20 mg , Once-daily and OPC-64005 10 mg , Once-daily in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 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 Japan. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period (time frame: Baseline, Week 1, 2, 3, 4, 5, and 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04244253.

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 19 Sep 2024.