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Completed

NCT Number: NCT01371721

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

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).

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Aranda de la Parra, S.A. de C.V., León, Guanajuato, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DVS SR

Drug

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

Primary outcomes

  1. Percentage of Participants Experiencing a Treatment Emergent Adverse Event

    Time frame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Secondary outcomes

  1. Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases

    Time frame: 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.

  2. Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases

    Time frame: 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.

  5. Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 13, 2011
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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