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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Phase 3 trial testing DVS SR in Major Depressive Disorder in 283 participants. Completed in 22 April 2016.
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 283 |
| Start date | 2 February 2012 |
| Primary completion | 22 April 2016 |
| Estimated completion | 22 April 2016 |
| Sites | 36 locations across Chile, United States |
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Adults 7 to 17, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 78.0 | |
| DVS-SR, Low Dose/DVS-SR | 73.1 | |
| DVS-SR, High Dose/DVS-SR | 71.1 |
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 74.0 |
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | -6.79 | ± 12.05 |
| DVS-SR, Low Dose/DVS-SR | -10.72 | ± 10.80 |
| DVS-SR, High Dose/DVS-SR | -8.57 | ± 13.01 |
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score \<=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | -8.63 | ± 12.03 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | -1.02 | ± 1.18 |
| DVS-SR, Low Dose/DVS-SR | -1.44 | ± 1.12 |
| DVS-SR, High Dose/DVS-SR | -0.70 | ± 1.37 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | -1.05 | ± 1.26 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value o
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 87.3 | |
| DVS-SR, Low Dose/DVS-SR | 94.7 | |
| DVS-SR, High Dose/DVS-SR | 89.3 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value o
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 90.3 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a va
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 54.0 | |
| DVS-SR, Low Dose/DVS-SR | 73.7 | |
| DVS-SR, High Dose/DVS-SR | 53.6 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 33.3 | |
| DVS-SR, Low Dose/DVS-SR | 21.1 | |
| DVS-SR, High Dose/DVS-SR | 35.7 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 9.5 | |
| DVS-SR, Low Dose/DVS-SR | 5.3 | |
| DVS-SR, High Dose/DVS-SR | 10.7 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 1.6 | |
| DVS-SR, Low Dose/DVS-SR | 0.0 | |
| DVS-SR, High Dose/DVS-SR | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 1.6 | |
| DVS-SR, Low Dose/DVS-SR | 0.0 | |
| DVS-SR, High Dose/DVS-SR | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 0.0 | |
| DVS-SR, Low Dose/DVS-SR | 0.0 | |
| DVS-SR, High Dose/DVS-SR | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 0.0 | |
| DVS-SR, Low Dose/DVS-SR | 0.0 | |
| DVS-SR, High Dose/DVS-SR | 0.0 |
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a va
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 60.2 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 30.1 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 8.5 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 0.0 |
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 0.0 |
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Placebo/DVS-SR | 73.0 | |
| DVS-SR, Low Dose/DVS-SR | 89.5 | |
| DVS-SR, High Dose/DVS-SR | 75.0 |
Remission on the CDRS-R was defined as a CDRS-R score \<=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Combination Group | 79.0 |
Time frame: From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Combination Group |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | — | — | — | — |
| Suicide attempt | Psychiatric disorders | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Ketoacidosis | Metabolism and nutrition disorders | — | — | — | — |
| Generalised tonic-clonic seizure | Nervous system disorders | — | — | — | — |
| Aggression | Psychiatric disorders | — | — | — | — |
| Hallucination, auditory | Psychiatric disorders | — | — | — | — |
| Initial insomnia | Psychiatric disorders | — | — | — | — |
| Major depression | Psychiatric disorders | — | — | — | — |
| Pyromania | Psychiatric disorders | — | — | — | — |
| Suicide threat | Psychiatric disorders | — | — | — | — |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Placebo/DVS-SR | DVS-SR, Low Dose/DVS-SR | DVS-SR, High Dose/DVS-SR | Combination Group |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Accidental overdose | Injury, poisoning and procedural complications | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Gastroenteritis viral | Infections and infestations | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Weight increased | Investigations | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — |
| Irritability | Psychiatric disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | — | — | — | — |
| Initial insomnia | Psychiatric disorders | — | — | — | — |
| Otitis media | Infections and infestations | — | — | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Increased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Psychomotor hyperactivity | Nervous system disorders | — | — | — | — |
| Self injurious behaviour | Psychiatric disorders | — | — | — | — |
| Dysmenorrhoea | Reproductive system and breast disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — | — | — |
Most-reported serious reactions: Suicidal ideation, Suicide attempt, Agitation, Femur fracture, Ketoacidosis, Generalised tonic-clonic seizure, Aggression, Hallucination, auditory.
Data from ClinicalTrials.gov NCT01371708 adverse events section.
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).
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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