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Depressive DisorderPhase 3NCT00866294

Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

A Phase 3 study testing paroxetine IR 10mg tablet, paroxetine IR 20mg tablet and Paroxetine CR 12.5mg tablet in people with Depressive Disorder, run by GlaxoSmithKline at 67 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Depressive Disorder
What is being tested?
paroxetine IR 10mg tablet, paroxetine IR 20mg tablet and Paroxetine CR 12.5mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
67 sitesin 2 countries
Study dates
Apr 2009to Feb 2010
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • <at the start of placebo run-in phase> Only the patients who meet all of the following conditions at Week -1 (at the start of placebo run-in phase) will be enrolled in this study. The hospitalization status will be no object. and Gender: No object.
  • Target disease: Patients diagnosed as having one of the following depressive disorders based on DSM-IV-TR classification in conjunction with M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) and showing currently a symptom of depression or depressed sate
  • Major depressive disorder, single episode (296.2) (excluding those accompanied by comorbid psychiatric disorders)
  • Major depressive disorder, recurrent (296.3) (excluding those accompanied by comorbid psychiatric disorders)
  • Age: >= 20 years (at the time of obtaining consent)
  • Consent: Patients from whom written consent to participate in this study can be obtained
Show all 17Show fewer
  • Gender:
  • Female patients of childbearing potential can be enrolled. But, such patients who can be enrolled are limited to only those who are negative in the pregnancy test performed at the start of the placebo run-in phase and who agree to receive a pregnancy test at the time point defined in the study period and surely perform any of the contraceptive methods.
  • Male subjects must abstain from (or use a condom during) sexual intercourse with a pregnant or lactating female. Male subjects must abstain from or use a condom plus spermicidal agent (foam/gel/film/cream/suppository) during sexual intercourse with a female of child-bearing potential.
  • Patients whose HAM-D (17 items) total score is >= 20 points
  • Patients whose duration of current episode at least 12 weeks but no longer than 24 months
  • Patients whose score of "depressed mood" (HAM-D Item 1) is >= 2 points
  • QTc<450 millisecond (msec) or <480 msec for patients with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.
  • For the purposes of these criteria, QTc B (Bazett's correction) is defined as (QT interval [msec]) /(square root of RR interval [seconds])
  • <at the start of treatment phase> Only the patients who meet all of the following conditions at Week -1 (at the start of the placebo run-in phase) and Week 0 (at the start of treatment phase) can be shifted to the treatment phase.
  • Patients whose HAM-D (17 items) total score is >=20 points
  • Patients whose score of "depressed mood" (HAM-D Item 1) is >=2 points

Who cannot join

  • <at the start of placebo run-in phase> The patients who are meeting any of the following conditions at Week -1 (at the start of placebo run-in phase) must not be enrolled in this study.
  • Patients whose primary diagnosis is a disorder classified to Axis I other than major depressive disorder in DSM-IV-TR classification (dysthymic disorder, eating disorder, specific phobia (monophobia), posttraumatic stress disorder, obsessive-compulsive disorder, panic disorder, etc.)
  • Patients with a current DSM-IV-TR Axis II diagnosis that suggested non-responsiveness to pharmacotherapy or non- compliance with the protocol (e.g., antisocial or borderline personality disorder)
  • Patients with a history or complication of another (non-MDD) mental disorder (schizophrenia, etc.)
  • Patients with a history or complication of manic episodes
  • Patients diagnosed as having an attentional deficit disorder or hyperactivity disorder
Show all 31Show fewer
  • Patients diagnosed as having a pervasive development disorder or mental retardation
  • Patients diagnosed as abusing or dependent on alcohol or drug within one year before the Week -1 visit
  • Patients who have undergone electroconvulsive therapy within one year before the Week -1 visit for the treatment of the current episode
  • Patients who have a history of treatment with depot neuroleptics
  • Patients with a history of serotonin syndrome or neuroleptic malignant syndrome
  • Patients with a >= 3-point score of "suicide" (HAM-D Item 3) or patients whose Columbia Suicide Severity Rating Scale (C-SSRS) assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (subinvestigator), are at significant risk for harming self or others.
  • Patients with a history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)
  • Patients who have taken another investigational product or a drug used in a post-marketing clinical study within 12 weeks before the Week -1 visit
  • Patients with glaucoma
  • Patients with a convulsive disorder such as epilepsy or a history of it
  • Patients using a drug increasing an onset risk of bleeding, patients with a bleeding tendency or bleeding diathesis
  • Patients complicated with severe renal or hepatic dysfunction
  • Patients complicated with serious organic brain disorder
  • Patients with a history or complication of cancer or malignant tumor
  • Patients complicated by chronic hepatitis B or C being positive in test of hepatitis B surface antigen (HbsAg) or hepatitis C antibody
  • Pregnant, lactating or possibly pregnant female patients, and female patients wishing to be pregnant during the study period
  • Patients who have previously been unresponsive to paroxetine therapy (e.g. >4wks unresponsive to paroxetine for depression).
  • Patients with a history of having discontinued treatment due to an adverse event caused by paroxetine
  • Patients with a history of hypersensitivity to paroxetine.
  • Patients judged ineligible to participate in this study by the investigator or subinvestigator
  • Exclusion criteria < at the start of treatment phase> The patients who are meeting any of the following conditions at Week 0 (at the start of treatment phase) must not be allowed to the treatment phase.
  • Patients with a 3 or more-point score of "suicide" (HAM-D Item 3) or with a strong suicidal tendency by C-SSRS and investigator clinical judgement.
  • Patients whose HAM-D (17 items) total score at the Week 0 visit has changed ±25 %, or exceeding the range of ±25 % of the score at the Week -1 visit
  • Patients whose Drug 1 (run-in placebo) compliance rate in the period from Week -1 to Week 0 has been < 80 %
  • Patients judged ineligible as the study subjects by the investigator or subinvestigator

Trial locations and contacts

67 sites in 2 countries.

67 sites in 2 countries

Japan58 sites

  • GSK Investigational Site

    Aichi, 453-0015

  • GSK Investigational Site

    Aichi, 468-0045

  • GSK Investigational Site

    Aichi, 479-0837

  • GSK Investigational Site

    Chiba, 272-0133

  • GSK Investigational Site

    Fukuoka, 802-0084

  • GSK Investigational Site

    Fukuoka, 802-8533

  • GSK Investigational Site

    Fukuoka, 810-0001

  • GSK Investigational Site

    Fukuoka, 810-0022

  • GSK Investigational Site

    Fukuoka, 811-0121

  • GSK Investigational Site

    Fukuoka, 815-0041

  • GSK Investigational Site

    Fukuoka, 819-0167

  • GSK Investigational Site

    Gunma, 379-0115

  • GSK Investigational Site

    Hokkaido, 060-0003

  • GSK Investigational Site

    Hokkaido, 060-0042

  • GSK Investigational Site

    Hokkaido, 063-0804

  • GSK Investigational Site

    Hyōgo, 651-0097

  • GSK Investigational Site

    Hyōgo, 657-0846

  • GSK Investigational Site

    Hyōgo, 660-0882

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Kanagawa, 220-0004

  • GSK Investigational Site

    Kanagawa, 221-0835

  • GSK Investigational Site

    Kanagawa, 223-0052

  • GSK Investigational Site

    Kanagawa, 231-0023

  • GSK Investigational Site

    Kanagawa, 238-0042

  • GSK Investigational Site

    Kanagawa, 244-0816

  • GSK Investigational Site

    Kanagawa, 251-0055

  • GSK Investigational Site

    Kumamoto, 861-8002

  • GSK Investigational Site

    Kyoto, 616-8421

  • GSK Investigational Site

    Nagano, 390-0303

  • GSK Investigational Site

    Nagano, 399-8695

  • GSK Investigational Site

    Osaka, 530-0041

  • GSK Investigational Site

    Osaka, 569-7711

  • GSK Investigational Site

    Osaka, 582-0025

  • GSK Investigational Site

    Osaka, 589-0011

  • GSK Investigational Site

    Saga, 840-0816

  • GSK Investigational Site

    Saga, 843-0023

  • GSK Investigational Site

    Saitama, 331-0081

  • GSK Investigational Site

    Saitama, 332-0012

  • GSK Investigational Site

    Saitama, 350-0046

  • GSK Investigational Site

    Saitama, 366-0824

  • GSK Investigational Site

    Tochigi, 321-0953

  • GSK Investigational Site

    Tokyo, 100-0006

  • GSK Investigational Site

    Tokyo, 107-0052

  • GSK Investigational Site

    Tokyo, 135-0061

  • GSK Investigational Site

    Tokyo, 141-0021

  • GSK Investigational Site

    Tokyo, 142-0051

  • GSK Investigational Site

    Tokyo, 151-0053

  • GSK Investigational Site

    Tokyo, 152-0012

  • GSK Investigational Site

    Tokyo, 154-0004

  • GSK Investigational Site

    Tokyo, 165-0033

  • GSK Investigational Site

    Tokyo, 166-0003

  • GSK Investigational Site

    Tokyo, 167-0042

  • GSK Investigational Site

    Tokyo, 167-0051

  • GSK Investigational Site

    Tokyo, 170-0002

  • GSK Investigational Site

    Tokyo, 173-0037

  • GSK Investigational Site

    Tokyo, 180-0005

  • GSK Investigational Site

    Tokyo, 192-0082

  • GSK Investigational Site

    Tottori, 682-0023

Other trials in Japan

South Korea9 sites

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 110-746

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 150-713

  • GSK Investigational Site

    Seoul, 156-707

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Controlled Release Paroxetine in the Treatment of Major Depressive Disorder

This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety based on adverse events, laboratory data and vital signs, and to describe the efficacy and safety of immediate release (IR) formulation of paroxetine.

Being tested
paroxetine IR 10mg tablet, paroxetine IR 20mg tablet, matched placebo to paroxetine IR 10mg or 20mg, Paroxetine CR 12.5mg tablet, Paroxetine CR 25mg tablet
Keywords
Immediate-release formulation of paroxetine (paroxetine IR), HAM-D (17 items), Controlled-release formulation of paroxetine (paroxetine CR)
Medical subject headings
Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paroxetine IR 10mg tabletDrug

    1 or 2 tablets once a day

  • paroxetine IR 20mg tabletDrug

    1 tablet once a day

  • matched placebo to paroxetine IR 10mg or 20mgDrug

    1 or 2 tablets once a day

  • Paroxetine CR 12.5mg tabletDrug

    1 or 2 tablets once a day

  • Paroxetine CR 25mg tabletDrug

    1 or 2 tablets once a day

  • matched placebo to paroxetine CR 12.5mg or 25mgDrug

    1 or 2 tablets once a day

Study groups in NCT00866294
Study groupRoleWhat they receive
paroxetine CR groupExperimentalcontrolled-release (CR) of paroxetine 12.5 to 50mg/day
Receives: Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: Paroxetine CR 12.5mg tablet; Drug: Paroxetine CR 25mg tablet; Drug: matched placebo to paroxetine CR 12.5mg or 25mg
paroxetine IR groupOtherImmediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm
Receives: Drug: paroxetine IR 10mg tablet; Drug: paroxetine IR 20mg tablet; Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: matched placebo to paroxetine CR 12.5mg or 25mg
placebo groupPlacebo comparatormatched placebo to both paroxetine CR and paroxetine IR
Receives: Drug: matched placebo to paroxetine IR 10mg or 20mg; Drug: matched placebo to paroxetine CR 12.5mg or 25mg

What is being measured

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

  1. Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8

    The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.

    Measured: Baseline (Week 0) and Week 8

Secondary outcomes (5)

  1. Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8

    The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.

    Measured: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8

  2. Percentage of HAM-D Responders at Weeks 4 and 8

    The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.

    Measured: Weeks 4 and 8

  3. Percentage of HAM-D Remitters at Weeks 4 and 8

    The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.

    Measured: Weeks 4 and 8

  4. Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8

    The 7-point CGI-SI scale assesses the clinician's impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.

    Measured: Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8

  5. Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8

    The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.

    Measured: Weeks 4 and 8

Timeline

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

  1. First posted20 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866294
Sponsor's protocol ID
112810
Status last verified
Dec 2016
First submitted
19 Mar 2009
Last updated
30 Jan 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Higuchi T, Hong JP, Jung HY, Watanabe Y, Kunitomi T, Kamijima K. Paroxetine controlled-release formulation in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled study in Japan and Korea. Psychiatry Clin Neurosci. 2011 Dec;65(7):655-63. doi: 10.1111/j.1440-1819.2011.02243.x. Epub 2011 Sep 6.

    PubMed 21895859

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paroxetine IR 10mg tablet, paroxetine IR 20mg tablet and Paroxetine CR 12.5mg tablet in people with Depressive Disorder, run by GlaxoSmithKline at 67 sites in 2 countries.

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 17 inclusion and 31 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Japan, South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Nov 2010). 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?

Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 (time frame: Baseline (Week 0) and Week 8). 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 NCT00866294, which also lists 1 linked publication.

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 30 Jan 2017.

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