A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01371721

Enrollment

269

Registered

2011-06-13

Start date

2012-02-29

Completion date

2015-10-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, MDD, Depression

Brief summary

This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).

Interventions

DRUGDVS SR

Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR * Willingness and ability to comply with scheduled visits, treatment plan and procedures

Exclusion criteria

* Subject requires precaution against suicide * Subject not in a generally healthy condition

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Experiencing a Treatment Emergent Adverse Event	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Secondary

Measure	Time frame	Description
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 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 = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study	A 7-point clinician rated scale ranging from 1 (very much improved) 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. Higher score = more affected.

Countries

Mexico, United States

Participant flow

Recruitment details

Participants who completed the 8-week, double-blind treatment phase of Desvenlafaxine Succinate Sustained Release (DVS SR B2061014 NCT01372150) and completed the 1-week transition phase (week 9) of the short-term study were eligible to participate in this study (DVS SR B2061031).

Participants by arm

Arm	Count
Placebo / DVS SR Placebo in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	87
Fluoxetine / DVS SR Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	89
Desvenlafaxine Succinate Sustained Release / DVS SR DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg - 50 mg in extension study B2061031	92
Total	268

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	5	4	5
Overall Study	Lack of Efficacy	2	4	3
Overall Study	Lost to Follow-up	8	2	6
Overall Study	Other	2	3	0
Overall Study	Protocol Violation	6	4	5
Overall Study	Randomized but not treated	1	0	0
Overall Study	Withdrawal by Subject	5	7	11

Baseline characteristics

Characteristic	Placebo / DVS SR	Fluoxetine / DVS SR	Desvenlafaxine Succinate Sustained Release / DVS SR	Total
Age, Continuous	12.5 Years STANDARD_DEVIATION 2.9	12.4 Years STANDARD_DEVIATION 3.01	12.8 Years STANDARD_DEVIATION 3.14	12.6 Years STANDARD_DEVIATION 3.01
Gender Female	47 Participants	39 Participants	49 Participants	135 Participants
Gender Male	40 Participants	50 Participants	43 Participants	133 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	47 / 87	61 / 89	62 / 92	170 / 268
serious Total, serious adverse events	5 / 87	2 / 89	3 / 92	10 / 268