SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Phase 3

Terminated

Conditions: Major Depressive Disorder

Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

Registration Number: NCT01436175

Lead Sponsor: Shire

Brief Summary: This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1570

Inclusion Criteria

Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

Exclusion Criteria

Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPD489 + Antidepressant	SPD489 (Lisdexamfetamine dimesylate) + Antidepressant	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Diastolic Blood Pressure at Week 52	Baseline, Week 52/ET	Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Columbia-Suicide Severity Rating Scale (C-SSRS)	Week 5 up to Week 52/Early Termination(ET)	C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Change From Baseline in Systolic Blood Pressure at Week 52	Baseline, Week 52/ET	Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Change From Baseline in Pulse Rate at Week 52	Baseline, Week 52/ET	Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).

Secondary Outcome Measures

Name	Time	Method
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities	Week 52/ET	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
Short Form-12 Health Survey Version 2 (SF-12V2)	Week 52/ET	SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.
Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)	Week 52/ET	Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET	Baseline, Week 52/ET	Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort	Week 52/ET	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility	Week 52/ET	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care	Week 52/ET	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression	Week 52/ET	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale	Week 52/ET	EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET	Baseline, Week 52/ET	CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
Amphetamine Cessation Symptom Assessment (ACSA) Total Score	Week 53	ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	Week 52/ET	QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)	Week 52/ET	The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.
PRUQ-MDD - Number of Hours	Week 52/ET	The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)	Week 52/ET	The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported.
PRUQ-MDD - Number of Days of Resource Utilization	Week 52/ET	The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)	Week 52/ET	The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.
PRUQ-MDD - Effect of Depressive Symptoms	Week 52/ET	The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.

Trial Locations

Locations (207): Birmingham Research Group
🇺🇸
Birmingham, Alabama, United States
ResearchOne, Inc.
🇺🇸
Scottsdale, Arizona, United States
Arkansas Psychiatric Clinical Research Trials, P.A.
🇺🇸
Little Rock, Arkansas, United States
South Coast Clinical Trials, Inc.
🇺🇸
Anaheim, California, United States
American Neuropsychiatric Research, Inc.
🇺🇸
Carson, California, United States
Catalina Research Institute, LLC
🇺🇸
Chino, California, United States
Shanti Clinical Trials
🇺🇸
Colton, California, United States
ATP Clinical Research
🇺🇸
Costa Mesa, California, United States
Clinical Innovation, Inc.
🇺🇸
Costa Mesa, California, United States
Diligent Clinical Trials
🇺🇸
Downey, California, United States
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Birmingham Research Group
🇺🇸Birmingham, Alabama, United States