Safety and Efficacy of Cariprazine as an Adjunctive to AntidepressantTherapy in Major Depressive Disorder

• Conditions: Major Depressive Disorder; MedDRA version: 15.0Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873; MedDRA version: 15.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-005179-18-SK
• Lead Sponsor: Forest Research Institute, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-12
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 810

Inclusion Criteria

To be eligible to participate in the study, patients must meet the following criteria:
1. Written informed consent, signed or thumbprinted (only if allowed by local
regulations), obtained from the patient before the initiation of any study-specific
procedures
2. Male or female outpatients 18 to 65 years of age, inclusive
3. Currently meet the DSM-IV-TR criteria for MDD without psychotic features based
on the Structured Clinical Interview for Diagnostic Statistic Manual of Mental Health
Disorders, Fourth Edition (SCID), with a current major depressive episode of at least
8 weeks and not exceeding 24 months in duration at Visit 1
4. Ongoing inadequate response to protocol allowed ADT (bupropion, citalopram,
desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or
vilazodone) administered at adequate dose and duration in accordance with the
respective package insert, documented in the Antidepressant Treatment History Form
(ATHF) with a resistance rating of = 3 and a global confidence score of = 3
5. Montgomery-Asberg Depression Rating Scale (MADRS) total score = 22 at both
Screening (Visit 1) and Baseline (Visit 2)
6. Normal physical examination findings, clinical laboratory results, and
electrocardiogram (ECG) results from Screening (Visit 1) or abnormal findings
judged not clinically significant by the PI and documented as such in the eCRF
7. Body mass index between 18 and 40, inclusive
8. If female of child bearing potential, have a negative serum ß-human chorionic
gonadotropin (ß-hCG]) pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 810
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Psychiatric Criteria:
1. Principal DSM-IV-TR–based diagnosis of an axis I disorder, other than MDD, or
any axis I disorder other than MDD that was the primary focus of treatment within
6 months before Visit 1 (secondary diagnoses of comorbid generalized anxiety
disorder, social anxiety disorder, or specific phobias are acceptable)
2. History of meeting DSM-IV-TR criteria for:
a. Any depressive episode with psychotic or catatonic features
b. Any manic, hypomanic or mixed episode, including bipolar disorder and
substance-induced (eg, antidepressant-induced) manic, hypomanic or mixed
episode
c. Schizophrenia, schizoaffective, or other psychotic disorder
d. Panic disorder, with or without agoraphobia
e. Obsessive-Compulsive disorder
f. Bulimia or Anorexia Nervosa
g. Dementia, amnesic, or other cognitive disorder
h. Mental retardation
3. Meeting full DSM-IV-TR criteria for MDD with seasonal pattern” AND the
patient’s season of remission would occur during the study.
4. DSM-IV-TR–based diagnosis of borderline or antisocial personality disorder or other
axis II disorder of sufficient severity to interfere with participation in this study
5. History of meeting DSM-IV-TR criteria for alcohol or substance abuse or dependence
(other than nicotine or caffeine) within the 6 months before Visit 1
6. Positive result on blood alcohol test or for any prohibited medication on the urine
drug screen with the following stipulations:
? Patients with a positive urine drug screen for cannabinoids, barbiturates, opiates,
amphetamines, or benzodiazepines may be allowed in the study provided that the
drug was used for a legitimate medical purpose and the use of such products can
be discontinued (documented by a negative repeat test) before participation
beyond screening
? Medically appropriate episodic use (up to 3 days) of narcotic analgesics for acute
medical indications is allowed
? Discussion with Medical Monitor is recommended in any potential exception
listed above
? Positive results for methadone, phencyclidine, and cocaine are exclusionary with
no exceptions
7. Suicide risk, as determined by meeting any of the following criteria:
? A suicide attempt within the past year
? Significant risk, as judged by the PI, based on the psychiatric interview or
information collected in the Columbia–Suicide Severity Rating Scale (C-SSRS) at
Visit 1 or Visit 2
? MADRS Item 10 score = 5 at Visit 1 or Visit 2
8. At imminent risk of injuring self or others or causing significant damage to property,
as judged by the PI
9. Requires hospitalization
Treatment-Related Criteria:
10. Treatment refractory depression as defined by:
? Failure to respond (< 50% reduction in depressive symptoms) to = 3 ADTs
given at adequate dose (as defined by the ADT package insert) and duration of
> 6 weeks during the present episode
? History of inadequate response to ECT, a monoamine oxidase inhibitor, or
adjunctive treatment with an antipsychotic
11. Having a history of treatment with clozapine or any depot antipsychotic (exception:
episodic use of clozapine at doses = 150 mg/day for the treatment of insomnia)
12. Having received any antipsychotic, anticonvulsant/mood stabilizer, anxiolytic,
benzodiazepine, or other ADT augmentation agent (eg, T3 [except as treatment for
thyroid condition], 2nd antidepressant, etc.) within 1 week or 5 half lives of the
medication, whichever is longer, prior to Visit 2; however, 4 weeks for T3, 2 weeks is

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified