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Major Depressive DisorderPhase 2NCT01582815

A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms

A Phase 2 study testing JNJ-40411813 in people with Major Depressive Disorder, run by Janssen Research & Development, LLC at 26 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
JNJ-40411813
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
26 sitesin 6 countries
Study dates
Sep 2012to Nov 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of Major Depressive Disorder (MDD); patients with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis
  • A 17-item Hamilton Depression Rating Scale (HDRS17) total score =>18
  • A HDRS17 anxiety/somatization factor score =>7
  • Is receiving an antidepressant

Who cannot join

  • Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
  • Has a length of current Major Depressive Episode (MDE) >6 months
  • Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
  • Not including the inadequate response to the current antidepressant, has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

Ukraine9 sites
  • Study site

    Donetsk

  • Study site

    Hlevakha

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Smila

  • Study site

    Uzhhorod

  • Study site

    Village Stepanovka Kherson

Other trials in Ukraine

Bulgaria5 sites
  • Study site

    Burgas

  • Study site

    Kazanlak

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Russia5 sites
  • Study site

    Nizny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    St-Peterburg

  • Study site

    Tomsk

Other trials in Russia

Hungary4 sites
  • Study site

    Baja

  • Study site

    Budapest

  • Study site

    Gyõr

  • Study site

    Kalocsa

Other trials in Hungary

Romania2 sites
  • Study site

    Arad

  • Study site

    Iași

Other trials in Romania

Moldova1 site
  • Study site

    Chisinau

Other trials in Moldova

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults With Major Depressive Disorder With Anxiety Symptoms

The purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.

Read the detailed description

This is a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled study in adult patients with Major Depressive Disorder (MDD) with anxiety symptoms of relevant severity. The study will consist of 3 phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a 2-week post-treatment (follow up) phase. Patients will continue to take the same daily dose of their antidepressant (as directed by the investigator) at the same time of day, from screening through the end of the study, including the post-treatment phase. The total study duration for each patient will be approximately 12 weeks.

Being tested
JNJ-40411813, Placebo
Keywords
Major Depressive Disorder, Depression, Anxiety symptoms, JNJ-40411813
Medical subject headings
Depressive Disorder, Major, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-40411813Drug

    Type= range, unit= mg, number= 25 to 150, form= capsules, route= oral administration. JNJ-40411813 will be administered twice daily during 8 weeks, following fixed and flexible schedules in which the dose can range from 25 mg to 150 mg.

  • PlaceboDrug

    Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.

Study groups in NCT01582815
Study groupRoleWhat they receive
JNJ-40411813ExperimentalNot described
Receives: Drug: JNJ-40411813
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score

    The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

    Measured: Baseline, Week 4

Secondary outcomes (14)
  1. The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score

    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

    Measured: Baseline, Week 4

  2. The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score

    The (HAM-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.

    Measured: Baseline, Week 4

  3. The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale

    The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Measured: Baseline, Week 4

  4. The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score

    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

    Measured: Baseline, Week 4

  5. The change from baseline to endpoint in the HAM-D6 score

    The HAM-D6 is a 6-item subscale derived from the Hamilton Depression Rating Scale (HDRS17). The rating scale measures the severity of depressive symptomatology. Higher scores represent more severe depressive symptoms.

    Measured: Baseline, Week 4

  6. The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score

    The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. Scores range from 0 to 84 with higher scores representing greater severity of depressive symptoms.

    Measured: Baseline, Week 6

  7. The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale

    The IDS-C30 is a clinician administered 30 item depression specific severity rating scale designed to measure specific signs and symptoms of depression including melancholic, atypical and anxious features. The anxiety subscale includes five anxiety symptoms: anxious mood, somatic complaints, sympathetic arousal, panic, and gastrointestinal symptoms. The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.

    Measured: Baseline, Week 4

  8. The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ)

    The WLQ is a 25-item questionnaire self-report rating scale developed to measure the on-the-job impact of chronic health problems and/or treatment ("work limitations"), with a recall period of the previous 2 weeks. It comprises four dimensions of limitations: handling time, physical, mental-interpersonal, and output demands. Patients respond to each item with options ranging from "Almost all of the time" to "none of the time", or "Does not apply to my job". The global score ranges from 0 to 100 with lower score indicating low level of work limitations.

    Measured: Baseline, Week 4

  9. The change from baseline to endpoint on the Perceived Stress Scale (PSS)

    The PSS is a 10-item, self-reported unidimensional instrument developed to measure perceived stress in response to situations in a person's life. Prevalence of an item within the last month is measured on a 5 point scale, ranging from "never" to "very often". Higher scores reflect higher levels of perceived stress.

    Measured: Baseline, Week 4

  10. The change from baseline to endpoint in the Profile of Moods Scale-Brief Form (POMS-BF)

    The POMS-BF is a 30 item, self-report inventory in which a series of mood states (such as "Tense" or "Worn out") are rated based on how well each item describes the respondent's mood during the past week, including today. Items are rated on a 5-point scale with response options of: "Not at all", "A little", "Moderately", "Quite a bit" or "Extremely" with a global score range of 0 to 120 or individual domain scores on Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Lower scores indicate better mood state.

    Measured: Baseline, Week 4

  11. The change from baseline to endpoint on the Medical Outcomes Study- 12-item Sleep Scale Acute - Revised (MOS Sleep-R)

    The MOS Sleep-R is a self-reported scale containing 12 items addressing dimensions of sleep. It comprises six subscales: sleep disturbance, snoring, shortness of breath or headache, sleep adequacy, sleep somnolence, and sleep quantity. Items are answered on 5-point scales, where 1="all of the time," and 5="none of the time," 1 item (sleep latency) is answered on a 5 point scale from 1="0-15 minutes" to 5="more than 60 minutes." Score range of 0 to 100, where higher scores indicate fewer sleep-related problems. Duration of sleep is scored as the average number of hours slept per night.

    Measured: Baseline, Week 4

  12. The number of patients with a Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor score ≥7 at Week 4

    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

    Measured: Week 4

  13. The number and percentage of patients with either ≥50% or ≥30% improvement on the HDRS17 total score at Week 4, and number and percentage of patients with HDRS 17 total score ≤ 7 at week 4

    The HDRS17 is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression with a score range of 0 to 52. Questions are related to symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss. The higher the score, the more severe the depression.

    Measured: Week 4

  14. The number of patients at Week 4 with ≥ 50% improvement on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score

    The (HAM-A) is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582815
Sponsor's protocol ID
CR100851
Other IDs
40411813DAX2001, 2011-006121-26
Status last verified
Jun 2015
First submitted
20 Apr 2012
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-40411813 in people with Major Depressive Disorder, run by Janssen Research & Development, LLC at 26 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Ukraine, Bulgaria, Russia, Hungary, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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