Depressive Disorder, MajorPhase 2NCT00048204

A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

A Phase 2 study testing GW597599B and paroxetine in people with Depressive Disorder, Major, run by GlaxoSmithKline.

Completed

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

Trial summary

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD) Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive Disorder, Major
What is being tested?: GW597599B and paroxetine
How many people: 372 participants
Where: No sites listed yet
Study dates: 4 Nov 2002to 30 Sep 2003
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients meet the diagnosis of Major Depressive Disorder (MDD).

Who cannot join

Patients with a primary diagnosis other than MDD.
Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
Patient is actively suicidal.
Patients who have a history of migraine headaches.

About this study

Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Conditions: Depressive Disorder, Major
Being tested: GW597599B, paroxetine
Keywords: Depression, Psychiatry, Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

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

GW597599BDrug
paroxetineDrug
Also called GW597599B

What is being measured

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

Hamilton Depression Rating Scale
Measured: 8 Weeks

Secondary outcomes (1)

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
Measured: 8 Weeks

Timeline

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

4 Nov 200230 Sep 2003

First posted30 Oct 2002 (estimated)
Study start4 Nov 2002
Primary completion30 Sep 2003
Study completion30 Sep 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Double blind
Enrolment: 372 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00048204
Sponsor's protocol ID: NKD20006
Status last verified: Oct 2017
First submitted: 28 Oct 2002
Last updated: 9 Oct 2017
Results posted: No
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.

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?

Official record

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00048204
Acronym / sponsor ID: NKD20006
Conditions: Depressive Disorder, Major
Keywords: Depression, Psychiatry, Major Depressive Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 372 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Nov 2002 (actual)
Primary completion: 30 Sep 2003 (actual)
Study completion: 30 Sep 2003
First posted: 30 Oct 2002 (estimated)
Results: Not posted in the source record

Clinical summary

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

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients meet the diagnosis of Major Depressive Disorder (MDD).

Key exclusion criteria (5 listed)

Patients with a primary diagnosis other than MDD.
Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
Patient is actively suicidal.
Patients who have a history of migraine headaches.

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
GW597599B	Drug	–
paroxetineAlso: GW597599B	Drug	–

Primary outcome

Hamilton Depression Rating Scale
Time frame: 8 Weeks

1 secondary outcome

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
Time frame: 8 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Depressive Disorder, Major

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW597599B and paroxetine in people with Depressive Disorder, Major, run by GlaxoSmithKline.

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 1 inclusion and 5 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hamilton Depression Rating Scale (time frame: 8 Weeks). 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 NCT00048204.

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 9 Oct 2017.