Depressive Disorder, Major Depressive Disorder Clinical Trial
Official title:
6-Month, Multicenter, Open-Label, Flexible-Dose Study To Evaluate Safety, Efficacy, And Tolerability Of Desvenlafaxine Succinate Sustained-Release Tablets In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
| Verified date | August 2021 |
| Source | Wyeth is now a wholly owned subsidiary of Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the treatment of child and adolescent outpatients with major depressive disorder in an exploratory manner.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Years to 18 Years |
| Eligibility | Inclusion Criteria: - Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term treatment. - Study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods. Exclusion Criteria: - Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of the preceding study 3151A6-2000. - Unresolved clinically significant adverse events or serious adverse events in the preceding study 3151A6-2000. - Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator and the medical monitor. - Other exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Hershey | Pennsylvania |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | North Miami | Florida |
| United States | Pfizer Investigational Site | Terre Haute | Indiana |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change From Baseline (Bsl) in Children's Depression Rating Scale - Revised (CDRS-R) Total Score at Final On-therapy Visit | CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. | Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination) | |
| Other | Percentage of Participants With Remission (Total Score =28) Based on Children's Depression Rating Scale - Revised (CDRS-R) | CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score =28 (coded value of 1). | Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) | |
| Other | Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score | HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states. | Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) | |
| Other | Percentage of Participants With a Categorical Clinical Global Impressions Scales - 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, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. | Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) | |
| Other | Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score | CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. | Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) | |
| Other | Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score | CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved). | Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29) | |
| Other | Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females | Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category. | Baseline (Extension study), Week 26 (Extension study) | |
| Other | Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males | Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category. | Baseline (Extension study), Week 26 (Extension study) | |
| Other | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP) | PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP =20 millimeters of mercury [mmHg] or in DBP =15 mmHg for the last supine to first standing BP [supine to standing]). | Baseline (Extension study) up to Week 26 (Extension study) | |
| Other | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight | Vitals signs meeting the PCI criteria for weight categorized according to an increase of =7 percent or a decrease of =3.5 percent in body weight. | Baseline (Extension study) up to Week 26 (Extension study) | |
| Other | Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate | PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse =20 bpm for last supine to first standing pulse [supine to standing]). | Baseline (Extension study) up to Week 26 (Extension study) | |
| Other | Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI) | ECG results meeting the criteria for PCI categorized as PR interval =200 milliseconds (msec); QT interval =480msec; QRS interval =120 msec; corrected QT (QTc) =500 msec ); >450 msec for males and >470 msec for females or increase of =60 msec or =30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula. | Baseline (Extension study) up to Week 26 (Extension study) | |
| Other | Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low) | PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age). | Baseline (Extension study) up to Week 26 (Extension study) | |
| Other | Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI) | Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of =4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value =1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) =2.258 mmol/L or increase =1.13 mmol/L and test value =3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones. | Baseline (Extension study) up to Week 26 (Extension study) | |
| Primary | Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) | AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect. | Baseline (Extension study) up to Extension study Week 29 Follow up visit | |
| Primary | Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category. | Postbaseline (=Day 1 in Core study NCT00619619) up to Week 26 (Extension study) |