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Major Depressive DisorderPhase 3NCT00095134

Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

A Phase 3 study testing risperidone in people with Major Depressive Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 70 sites in United States.

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 purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
risperidone
How many people
630 participants
Where
70 sitesUnited States
Study dates
Oct 2004to Nov 2005
Phase
Phase 3
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

  • Understand and sign the informed consent form
  • Age 18-65
  • Healthy on the basis of Physical Exam
  • Treatment with a single antidepressant 4 weeks prior to study start and willingness to maintain on stable dose of the same antidepressant throughout the study
  • Current diagnosis of Major Depressive Disorder
  • Judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant

Who cannot join

  • Presence of other serious medical illness(es)

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

United States70 sites

  • ABQ Med., P.C.

    Albuquerque, New Mexico, 81709

  • Alliance Medical Center, PC

    Alliance, Nebraska, 69301

  • Allan B. Aven, MD

    Arlington Heights, Illinois, 60005

  • American Health Network

    Avon, Indiana, 46123

  • DiscoveResearch, Inc.

    Beaumont, Texas, 77701

  • Innovative Clinical Trials, LLC

    Birmingham, Alabama, 35205

  • Greystone Medical Research

    Birmingham, Alabama, 35242

  • Southwestern Research Institute

    Burbank, California, 91506

  • Professional Clinical Research at Great Lakes Family Care

    Cadillac, Michigan, 49601

  • Community Health Care, Inc.

    Canal Fulton, Ohio, 44614

  • Community Research Management Associates, Inc.

    Cincinnati, Ohio, 45219

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • CFP Research, Inc.

    Cincinnati, Ohio, 45242

  • South Texas Applied Research

    Corpus Christi, Texas, 78411

  • Martin Schear, MD

    Dayton, Ohio, 45406

  • Gateway Medical

    Downingtown, Pennsylvania, 19335

  • Sooner Clinical Research

    Edmond, Oklahoma, 73013

  • Advanced Clinical Trials

    Eugene, Oregon, 97401

  • Research Solutions - Evansville

    Evansville, Indiana, 47714

  • Feasterville Family Health Care

    Feasterville, Pennsylvania, 19053

  • Hartford Research Group

    Florence, Kentucky, 41042

  • Leonard Bass, MD, PA

    Fort Lauderdale, Florida, 33311

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Clinical Trial Associates

    Glendora, New Jersey, 08029

  • The Family Practice

    Greer, South Carolina, 29651

  • Amy Kaissar, MD

    Indianapolis, Indiana, 46260

  • Chrishard Clinical Research

    Inglewood, California, 90301

  • Roger Miller, MD

    Jacksonville, Florida, 32257

  • Harmony Clinical Research

    Johnson City, Tennessee, 37601

  • Richard Neiman, MD

    Kirkland, Washington, 98034

  • Optimum Health Services

    La Mesa, California, 91942

  • Detweiler Family Medicine

    Lansdale, Pennsylvania, 19446

  • Green & Seidner Family Practice

    Lansdale, Pennsylvania, 19466

  • Woodburne Family Practice

    Levittown, Pennsylvania, 19057

  • Pacific Insititute for Medical Research

    Los Angeles, California, 90024

  • Clinical Research Consultants/Providence Medical

    Medford, Oregon, 97504

  • Medford Medical Clinic, LLP

    Medford, Oregon, 97504

  • New Orleans Medical Institute

    Metairie, Louisiana, 70001

  • Med-line Research

    Moore, Oklahoma, 73160

  • nTouch Research - Chicago

    Naperville, Illinois, 60542

  • Psychiatric Medicine Center

    New London, Connecticut, 06320

  • Eastside Comprehensive Medical Services, LLC

    New York, New York, 10021

  • Glasgow Family Practice

    Newark, Delaware, 19702

  • Pearl Clinical Research

    Norristown, Pennsylvania, 19401

  • BioQuan Research Group, Inc.

    North Miami, Florida, 33161

  • Optimum Health Services

    Oceanside, California, 92056

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73120

  • nTouch Research - Peoria

    Peoria, Illinois, 61602

  • Balanced Health Research Center

    Peoria, Illinois, 61614

  • Joseph Rybicki, MD

    Philadelphia, Pennsylvania, 19152

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Consolidated Clinical Trials, Inc.

    Pittsburgh, Pennsylvania, 15221

  • Charles Buttz, MD

    Pottstown, Pennsylvania, 19465

  • Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • Research Across America

    Reading, Pennsylvania, 19606

  • International Clinical Research Associates, LLC

    Richmond, Virginia, 23294

  • Behavioral Health 2000, LLC

    Riverside, California, 92506

  • Family Practice - St. Cloud

    Saint Cloud, Florida, 34769

  • nTouch Research

    San Diego, California, 92103

  • Scottsdale Family Health

    Scottsdale, Arizona, 85251

  • Brentwood Research Institute

    Shreveport, Louisiana, 71101

  • Daniel Blizzard, MD

    Spokane, Washington, 99216

  • Sam Hawatmeh, MD, PC

    St Louis, Missouri, 63125

  • Sun Valley Medical

    Sun City, Arizona, 85351

  • Clinco

    Terre Haute, Indiana, 47802

  • Southwest Biomedical Research Foundation

    Tucson, Arizona, 85711

  • Partners in Primary Care

    Turnersville, New Jersey, 08012

  • International Clinical Research Associates

    Virgina Beach, Virginia, 23452

  • Family Practice Center of Wadsworth

    Wadsworth, Ohio, 44281

  • Salem Research Group

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.

Read the detailed description

Many patients who suffer from Major Depressive Disorder (MDD) do not benefit or show only partial benefit from current psychotropic therapy. This clinical trial seeks to study the efficacy and safety of adjunctive treatment with risperidone in patients with MDD who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy (SAD).

Patients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks, and provided the dose was optimal, will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial.

If the dose in the four weeks prior to entering the study was not optimal (as per standard clinical practice), the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases.

During the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo, once daily, added to their stable dose of SAD. The starting dose of risperidone or placebo is 0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for days 4 through 14. On the 15th day of this phase, the dose is increased to the target dose of 1.0 mg/day. If response to this dose is not optimal by day 29, it is increased to 2.0 mg/day and is maintained for the duration of the 6-week double-blind phase. This dose may be reduced once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.

Being tested
risperidone
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.

What is being measured

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

  1. Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.

Secondary outcomes (1)

  1. Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).

Timeline

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

  1. First posted1 Nov 2004 (estimated)
  2. Study startOct 2004
  3. Study completionNov 2005

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
Double blind
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095134
Sponsor's protocol ID
CR004726
Status last verified
Dec 2011
First submitted
1 Nov 2004
Last updated
6 Dec 2011
Results posted
No

Publications

  • Pandina G, Turkoz I, Bossie C. Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder. J Affect Disord. 2013 Oct;151(1):384-91. doi: 10.1016/j.jad.2013.01.053. Epub 2013 Jul 10.

    PubMed 23849714

  • Mahmoud RA, Pandina GJ, Turkoz I, Kosik-Gonzalez C, Canuso CM, Kujawa MJ, Gharabawi-Garibaldi GM. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. doi: 10.7326/0003-4819-147-9-200711060-00003.

    PubMed 17975181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risperidone in people with Major Depressive Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 70 sites in United States.

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 6 inclusion and 1 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 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States. 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. 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?

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?

Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.. 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 NCT00095134, which also lists 2 linked publications.

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 6 Dec 2011.

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