Clinical trial NCT01582815: A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Anxiety symptoms
JNJ-40411813
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-04-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint in the HAM-D6 score
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score
timeFrame: Baseline, Week 6
measure: The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale
timeFrame: Baseline, Week 4
measure: The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ)
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint on the Perceived Stress Scale (PSS)
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint in the Profile of Moods Scale-Brief Form (POMS-BF)
timeFrame: Baseline, Week 4
measure: The change from baseline to endpoint on the Medical Outcomes Study- 12-item Sleep Scale Acute - Revised (MOS Sleep-R)
timeFrame: Baseline, Week 4
measure: The number of patients with a Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor score ≥7 at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 4
measure: 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
timeFrame: Week 4
Other outcomes:
Locations:
city: Bourgas
country: Bulgaria
city: Kazanlak
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Gyõr
country: Hungary
city: Kalocsa
country: Hungary
city: Chisinau
country: Moldova, Republic of
city: Arad
country: Romania
city: Iasi
country: Romania
city: Nizny Novgorod
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Peterburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Donetsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Smela
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Village Stepanovka Kherson
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References: