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| ID | Type | Description | Link |
|---|---|---|---|
| 3151A1-4420 |
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A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| desvenlafaxine succinate sustained-release 50 mg/day | Experimental |
| |
| desvenlafaxine succinate sustained-release 100 mg/day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine succinate sustained-release 50 mg/day | Drug | 50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline. | Baseline to Week 8 (final on-therapy) |
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline | Baseline to Week 8 (final on-therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome. | Baseline to Week 8 (final on-therapy) |
| Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dedicated Clinical Research | Phoenix | Arizona | 85020 | United States | ||
| Deidcated Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34183490 | Derived | Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435. | |
| 26709542 | Derived | McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Subjects were screened up to 2 weeks.
Subjects were recruited in the United States from October 2011 to May 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. |
| FG001 | DVS SR 50 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| desvenlafaxine succinate sustained-release 100 mg/day | Drug | 100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day |
|
| placebo | Drug | 50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper |
|
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. |
| Baseline to Week 8 (final on-therapy) |
| Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. | Baseline to Week 8 (final on-therapy) |
| Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score. | Baseline to Week 8 (final on-therapy) |
| Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7. | Baseline to week 8 (final on-therapy) |
| Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function. | Baseline to Week 8 (final on-therapy) |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Arkansas Psychiatric Clinic Clinical Research Trials, P.A. | Little Rock | Arkansas | 72223 | United States |
| Pacific Clinical Research Medical Group | Arcadia | California | 91007 | United States |
| Southwestern Research, Incorporated | Beverly Hills | California | 90210 | United States |
| Clinical Innovations, Inc. | Costa Mesa | California | 92626 | United States |
| Synergy Clinical Research of Escondido | Escondido | California | 92027 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| Pasadena Research Institute, LLC | Pasadena | California | 91106 | United States |
| Clinical Innovations, Inc. | Riverside | California | 92506 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| Clinical Innovations, Inc. | San Diego | California | 92121 | United States |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | United States |
| Viking Clinical Research Center | Temecula | California | 92591 | United States |
| Collaborative Neuroscience Network, Inc. South Bay | Torrance | California | 90502 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Clinical Neuroscience Solutions Incorporated | Jacksonville | Florida | 32216 | United States |
| Accurate Clinical Trials, Inc. | Kissimmee | Florida | 34741 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Comprehensive NeuroScience, Inc. | St. Petersburg | Florida | 33716 | United States |
| Janus Center for Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| Comprehensive NeuroScience, Incorporated | Atlanta | Georgia | 30328 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | United States |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Via Christi Research | Wichita | Kansas | 67214 | United States |
| Pharmasite Research Inc | Baltimore | Maryland | 21208 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63301 | United States |
| Heartland Pharma Development | North Platte | Nebraska | 69101 | United States |
| CRI Worldwide, LLC | Marlton | New Jersey | 08053 | United States |
| Social Psychiatry Research Institute | Brooklyn | New York | 11235 | United States |
| Neurobehavioral Research, Inc | Cedarhurst | New York | 11516 | United States |
| Eastside Comprehensive Medical Center, LLC | New York | New York | 10021 | United States |
| Medical and Behavioral Health Research Pc | New York | New York | 10023 | United States |
| Prairie St. Johns Clinic - Fargo | Fargo | North Dakota | 58103 | United States |
| Odyssey Research | Fargo | North Dakota | 58104 | United States |
| Plains Medical Clinic | Fargo | North Dakota | 58104 | United States |
| NorthCoast Clinical Trials Inc. | Beachwood | Ohio | 44122 | United States |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | United States |
| Patient Priority Clinical Sites, LLC | Cincinnati | Ohio | 45215 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| Oregon Center for Clinical Investigations, Inc. | Portland | Oregon | 97210 | United States |
| Summit Research Network (Oregon), Inc. | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| Lincoln Research | Lincoln | Rhode Island | 02865 | United States |
| Carolina Clinical Research Services | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials | Austin | Texas | 78731 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Radiant Research, Inc. | Murray | Utah | 84123 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | United States |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | United States |
| 25758058 | Derived | Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26. |
| 25375652 | Derived | Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978. |
| FG002 | DVS SR 100 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The numbers are correct. Participants flow starts with all randomized subjects while baseline is summarized for safety population defined as randomized AND took at least one dose. Started- (Other Did not take study drug) is the number for baseline summary.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. |
| BG001 | DVS SR 50 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. |
| BG002 | DVS SR 100 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline. | Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate. | Posted | Mean | Standard Error | Units on a scale | Baseline to Week 8 (final on-therapy) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline | Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data. | Posted | Mean | Standard Error | Units on a scale | Baseline to Week 8 (final on-therapy) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome. | Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data. | Posted | Number | number of participants | Baseline to Week 8 (final on-therapy) |
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| Secondary | Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. | Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 8 (final on-therapy) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state. | Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 8 (final on-therapy) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score. | Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used. | Posted | Number | percentage of the number of participants | Baseline to Week 8 (final on-therapy) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7. | Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used. | Posted | Number | percentage of the number of participants | Baseline to week 8 (final on-therapy) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score | The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function. | Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline. | Posted | Mean | Standard Error | Units on a scale | Baseline to Week 8 (final on-therapy) |
|
Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. | 6 | 300 | 110 | 300 | ||
| EG001 | DVS SR 50 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. | 2 | 300 | 159 | 300 | ||
| EG002 | DVS SR 100 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. | 2 | 309 | 163 | 309 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | Lymphadenopathy | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | Atrial fibrillation | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | Constipation | Systematic Assessment |
| |
| Hyperthermia | General disorders | Hyperthermia | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | Intentional overdose | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | Lower limb fracture | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | Abnormal ECG | Systematic Assessment |
| |
| Serum serotonin increased | Investigations | Significantly elevat | Systematic Assessment | Significantly elevated serotonin level |
|
| Motor dysfunction | Nervous system disorders | Impaired motor | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | Abnormal behavior | Systematic Assessment | Abnormal behavior as a result of reaction to alcohol and unknown substance |
|
| Depressive symptom | Psychiatric disorders | Increased depressive | Systematic Assessment | Increased depressive symptoms |
|
| Suicidal ideation | Psychiatric disorders | Suicidal ideation | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Constipation | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | Diarrhoea | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | Dry mouth | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | Nausea | Systematic Assessment |
| |
| Fatigue | General disorders | Fatigue | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | Decreased appetite | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | Dizziness | Systematic Assessment |
| |
| Headache | Nervous system disorders | Headache | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | Daytime drowsiness | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | Insomnia | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided). | Mixed Models Analysis | < 0.001 | A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms. | Adjusted Mean Difference | 1.96 | 2-Sided | 95 | 0.84 | 3.08 | No | Superiority or Other |
| DVS SR 100 mg |
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
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| OG002 |
| DVS SR 100 mg |
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
|
|
|
| OG002 |
| DVS SR 100 mg |
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
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| OG002 | DVS SR 100 mg | Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. |
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