Major Depressive Disorder (MDD)Phase 2NCT00448292
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
A Phase 2 study testing PRX-00023 in people with Major Depressive Disorder (MDD), run by Epix Pharmaceuticals, Inc. at 21 sites in United States.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- PRX-00023
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 21 sitesUnited States
- Study dates
- Mar 2007to Nov 2007
- Phase
- Phase 2
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
- Diagnosis of major depressive disorder
Who cannot join
- Females who are pregnant or nursing
- Electroconvulsive therapy within previous year
- Type 1 diabetes or uncontrolled type 2 diabetes
- HIV, Hepatitis B or Hepatitis C
- Use of illegal drugs, history of drug abuse, and/or alcohol dependence
- Clinically significant abnormal lab results
- Other protocol-defined eligibility criteria may apply.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
Northwest Clinical Research Center
Bellevue, Washington, 98004
SE Health Consultants, LLC
Charleston, South Carolina, 29407
Piedmont Neuropsychiatry
Charlotte, North Carolina, 28216
Chicago Research Center, Inc.
Chicago, Illinois, 60634
University of Texas - Southwestern Medical Center
Dallas, Texas, 75235
Pharmacology Research Institute
Encino, California, 91316
CNS Healthcare of Jacksonville
Jacksonville, Florida, 32216
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Pharmacology Research Institute
Los Alamitos, California, 90720
Vista Medical Research, Inc.
Mesa, Arizona, 85206
Synergy Clinical Research Center
National City, California, 91950
Excell Research
Oceanside, California, 92056
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
University of Pennsylvannia
Philadelphia, Pennsylvania, 19140
Pacific Clinical Research Medical Group
Riverside, California, 92506
Summit Research Network
Seattle, Washington, 98104
Brentwood Research Institute
Shreveport, Louisiana, 71101
AVI Clinical Research
Torrance, California, 90505
Pacific Clinical Research Medical Group
Upland, California, 91786
GWU Clinical Psychiatric Research Center
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of PRX-00023 in Patients With Major Depressive Disorder.
The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.
Read the detailed description
Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- PRX-00023, Placebo for PRX-00023
- Keywords
- Depression, Major Depressive Disorder, Major Depression, MDD
- 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.
PRX-00023Drug
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Placebo for PRX-00023Drug
Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PRX-00023 taken twice daily, escalating from 40 mg to 80 mg to 120 mg Receives: Drug: PRX-00023 |
| 2 | Placebo comparator | Placebo taken twice daily, escalating from 40 mg to 80 mg to 120 mg Receives: Drug: Placebo for PRX-00023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
Measured: change from baseline through end of study
Secondary outcomes (6)
Side effects during and immediately following the treatment period
Measured: assessed throughout study
changes from baseline on the Hamilton Anxiety Rating (HAM-A) scale
Measured: change from baseline through end of study
changes from baseline on the Quick Inventory of Depressive Symptomatology-self report (QIDS-SR)
Measured: change from baseline through end of study
changes from baseline on the Clinical Global Impressions (CGI) scale
Measured: change from baseline through end of study
responder and remission rates
Measured: change from baseline through end of study
changes from baseline on the Changes in Sexual Function (CSFQ) scale.
Measured: change from baseline through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startMar 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448292
- Sponsor's protocol ID
- EPX-CP-020
- Status last verified
- Nov 2007
- First submitted
- 13 Mar 2007
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- No