Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

NCT01134731 | Completed Phase 4 Results

• 1 other identifier: F100329001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects. Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.

Conditions

Major Depressive Disorder; Suicidal Ideation

Keywords

depression; suicidality; Major Depressive Disorder, current episode, with suicidality

Outcome Measures

Primary Outcomes (1)

• Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment

  The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.

  baseline to 12 weeks

Secondary Outcomes (1)

• Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment

  baseline to 12 weeks

Study Arms (3)

paliperidone

EXPERIMENTAL

dose escalation , levels 1-5 daily dosing ranged from 1-5mg

Drug: paliperidone

lithium

ACTIVE COMPARATOR

dose escalation, level 1-5 daily dosing 300-1500mg

Drug: lithium

placebo

PLACEBO COMPARATOR

1-5 placebo capsules

Drug: Placebo

Interventions

paliperidone DRUG

1-5 mg daily (QD)

paliperidone

lithium DRUG

300-1500mg QD

lithium

Placebo DRUG

1-5 placebo capsules

placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects who are able to provide informed consent
• years of age
• Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of MDD by MINI International Neuropsychiatric Interview (MINI) and confirmed by psychiatric interview
• Currently experiencing a depressive episode with suicidality (defined as having current suicidal thoughts occurring at least 3 out of 7 days in a week).
• Montgomery-Asberg Depression Rating Scale (MADRS) must include a total score \> 25 and a suicidal sub-score \> 4.

You may not qualify if:

• Depressed patients without suicidality, patients with severe psychotic features or with primary diagnoses of bipolar disorder (BD), schizophrenia, schizoaffective disorder, or generalized anxiety disorder (GAD), and subjects who have been taking lithium or an antipsychotic in the past 2 weeks
• Those with uncontrolled medical illnesses. Participants must be on any new medications for at least 30 days to be considered medically stable.
• For patients with panic disorder, post-traumatic stress disorder (PTSD), borderline personality disorder (BPD), etc. be sure that MDD is the primary diagnosis. When in doubt, decisions will be made on a case-by-case basis.
• Pregnant women.
• Allergic to paliperidone, to any other ingredient in paliperidone ER or paliperidone palmitate, or to risperidone.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Foundation for Suicide Prevention: collaborator
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation; Depression

Interventions

Paliperidone Palmitate; Lithium

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Limitations and Caveats

The inherent risk of the condition and concerns about the safety of the study, the high risk of impulsive and aggressive behavior, and high levels of distress making placebo-controlled studies difficult. Placebo arm terminated early due to dropout.

Results Point of Contact

• Title: Dr. Richard Shelton
• Organization: UAB

rshelton@uab.edu

205-934-2484

Study Officials

• Richard C Shelton, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 3, 2016
• Results First Posted: January 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)