Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

ClinicalTrials.gov ID

NCT00707980

Acronym / sponsor ID

LuAA21004_301

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, Depression, Melancholia, Mood Disorder, Dysthymic Disorder, Drug Therapy

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

836 participants (actual)

Lead sponsor

TakedaIndustry (pharma, biotech, devices)

Collaborators

H. Lundbeck A/S

Study start

Jun 2008

Primary completion

Jul 2010 (actual)

Study completion

Aug 2010 (actual)

First posted

2 Jul 2008 (estimated)

Results

Posted 13 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 to 76 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Physical Examination Findings

   Time frame: Baseline and Week 52

   Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area. Each system was assessed as normal or abnormal.

2. Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings

   Time frame: Weeks 4, 8, 12, 20, 28, 36, 44 and 52

   Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.

3. Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

   Time frame: Weeks 4, 12, 24, 36 and 52

   A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.

4. Number of Participants With Adverse Events (AEs)

   Time frame: From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)

   The intensity (severity) of each AE was defined as: * Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities. * Moderate: sufficiently uncomfortable to produce some impairment of normal activities. * Severe: incapacitating, preventing the patient from participating in normal activities. The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion.

5. Number of Participants With Potentially Clinically Significant Vital Sign Findings

   Time frame: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52

   Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

• Not yet recruiting

  Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences

  Adverse Childhood Experience, Depression / Major Depressive Disorder

• RecruitingPhase 4

  Biomarker-Guided Antidepressant Selection

  Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)

• Recruiting

  Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics

  Major Depressive Disorder, Apathy

• RecruitingObservational study

  Student Precarity and Psychiatry

  Depressive Disorder, Major, Generalized Anxiety Disorder

• Not yet recruiting

  Acute Intermittent Hypoxia Therapy for Depression

  Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

92 sites in 17 countries: see every site and its status.