Depressive Disorder, Major Clinical Trial
Official title:
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active Controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/Day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/Day) in Subjects With Major Depressive Disorder
| Verified date | May 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Effects of two depression medication on sexual functioning
| Status | Completed |
| Enrollment | 347 |
| Est. completion date | May 2005 |
| Est. primary completion date | May 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Primary diagnosis of Major Depressive Disorder (MDD) - must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years. - HAM-D17 total score of >17 at screening and baseline. - Severity of illness score of >4 at screening and baseline. - Willing to discuss sexual functioning with investigator or designee. - Sexual activity that leads to orgasm at least every 2 weeks. Exclusion Criteria: - Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s). - Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months. - Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal. - Myocardial infarction with 1 year of screening. - Taken ibupropion hydrochloride or venlafaxine in the last 6 months. - Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months. - Psychotherapy within 3 months. - Pregnant. - Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening. - ECG or clinical evidence of atrial or ventricular hypertrophy. |
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Bellaire | Texas |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Braintree | Massachusetts |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Burbank | California |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Charlottesville | Virginia |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Coral Springs | Florida |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Eugene | Oregon |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Greenfield | Massachusetts |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | La Mesa | California |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lincoln | Rhode Island |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Middleton | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Oak Brook | Illinois |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Rockville | Maryland |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Smyrna | Georgia |
| United States | GSK Investigational Site | Temecula | California |
| United States | GSK Investigational Site | Toledo | Ohio |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12. | |||
| Secondary | Efficacy, Safety, Tolerability, Health Outcome |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
| Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
| Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
| Recruiting |
NCT05988333 -
Psychoeducational Intervention for Families With a Member Affected by Major Depression
|
N/A | |
| Completed |
NCT02919501 -
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
|
Phase 2 | |
| Completed |
NCT00976560 -
Clinical Study to Test a New Drug to Treat Major Depression
|
Phase 2 | |
| Recruiting |
NCT05518149 -
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
|
Phase 3 | |
| Not yet recruiting |
NCT06303076 -
Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial
|
Phase 4 | |
| Not yet recruiting |
NCT05901571 -
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
|
N/A | |
| Suspended |
NCT02546024 -
Predictors of Treatment Response in Late-onset Major Depressive Disorder
|
N/A | |
| Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
| Completed |
NCT01583400 -
Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
|
N/A | |
| Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
| Completed |
NCT01152996 -
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
|
Phase 3 | |
| Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
| Completed |
NCT00366652 -
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
|
Phase 3 | |
| Completed |
NCT00369343 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT00384033 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
|
Phase 3 | |
| Completed |
NCT00149643 -
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
|
Phase 2 | |
| Terminated |
NCT04951609 -
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy
|
Phase 1 |