Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

ClinicalTrials.gov ID

NCT01121536

Acronym / sponsor ID

C10953/3074

Conditions

Depression

Keywords

Bipolar I Disorder

Phase

Phase 3

Study type

Interventional

Recruitment status

TerminatedReason stopped: Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons.

Enrolment

867 participants (actual)

Lead sponsor

CephalonIndustry (pharma, biotech, devices)

Study start

30 Apr 2010 (actual)

Primary completion

31 Oct 2013 (actual)

Study completion

31 Oct 2013 (actual)

First posted

12 May 2010 (estimated)

Results

Posted 26 Jan 2015

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 65 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. Participants With Treatment-Emergent Adverse Events (TEAE)

   Time frame: Day 1 up to Month 6

   AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.

2. Participants With Clinically Significant Abnormal Serum Chemistry Values

   Time frame: Day 1 to Month 6

   Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women. * GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L * ALT = alanine aminotransferase with a normal range of 6-43 U/L * BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L * AST = aspartate aminotransferase with a normal range of 9-36 U/L

3. Participants With Clinically Significant Abnormal Hematology Values

   Time frame: Day 1 to Month 6

   Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row. * ULN=upper limit of normal * WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L. * Hemoglobin with a normal range of 115-181 g/L * Hematocrit with a normal range of 0.34-0.54 L/L * Platelet counts with a normal range of 130-400 10^9/L * ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L

4. Participants With Clinically Significant Abnormal Urinalysis Values

   Time frame: Day 1 to Month 6

   Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.

5. Participants With Clinically Significant Abnormal Vital Signs Values

   Time frame: Day 1 to Month 6

   Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria: * Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline * Pulse low: <=50 bpm and decrease of >=15 bpm from baseline * Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline * Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline * Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline * Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline

6. Change From Baseline to Endpoint in Electrocardiogram (ECG) Values

   Time frame: Day 0 (baseline), Month 6 or last post-baseline observation

   ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination). RR= inter-beat intervals

7. Physical Examination Shifts From Baseline to Endpoint

   Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)

   Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint. HEENT = Head, Eye, Ear, Nose and Throat exam

8. Change From Baseline to Endpoint in Body Weight

   Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)

   Baseline was the score before the first dose of study drug in the double-blind study.

9. Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

   Time frame: Day 0 (baseline), Month 6 or last post-baseline observation

   The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. Baseline was the score before the first dose of study drug in the double-blind study.

10. Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV)

    Time frame: Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit

    The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated. - C-SSRS=Columbia Suicide Severity Rating Scale

11. Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

    Time frame: Day 0 (baseline), Month 6 (or last post-baseline observation)

    The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.

12. Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

    Time frame: Day 0 (baseline), Month 6 or last post-baseline observation

    HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. Baseline was the score before the first dose of study drug in the double-blind study.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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