Efficacy of Memantine add-on in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Patients (ARIQUELI-ME)

October 2, 2019 updated by: Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

Efficacy of the Combination of Memantine in the Treatment of Bipolar Disorder (Type I) Nonresponders or Partial Responders Young Patients to Previous Combination Therapy of Quetiapine Plus Lithium or Quetiapine Plus Aripiprazole

The main goal of this study is evaluate the efficacy of memantine association on the treatment with a previous combination of two drugs, including quetiapine with lithium or quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders to that combination of drugs and evaluate the impact of this association at the cognitive functioning of the patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Current evidence suggests that deregulation of brain glutamatergic neurotransmission is involved in the pathophysiology of bipolar disorder and that drugs that intervene in this transmission may be therapeutic weapons in addressing the symptoms and cognitive deficits of this pathology. Among these drugs, particularly memantine is a strong candidate in view of their efficacy in antagonizing N-methyl-D-aspartate (NMDA) receptors, and their good safety and tolerability profile. The principal aim of this study is to evaluate the efficacy of memantine association with treatment with a combination of two drugs, including quetiapine with lithium and quetiapine with aripiprazole in young patients with bipolar disorder type 1 non-responders or partial responders and evaluate the impact of this association cognitive functioning of patients. An experimental study, randomized, double-blind, bipolar patients with type 1, of both sexes, aged 18 to 40, ambulatory or hospitalized, at any stage of the disease, seeking treatment in the Mood Disorders Program (GRUDA) of Institute os Psychiatry (IPq) of Sao Paulo University (FMUSP). Patients will come from ARIQUELI Project (Missio, G. et al, 2013 submitted Trial registration - ClinicalTrials.gov Identifier:. NCT01710163).

The study will be conducted in two stages: I - initial administration of memantine or placebo for 8 weeks; II - Maintenance administration for more 4 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Frederico N. Demetrio, MD, PhD
  • Phone Number: +55 (11) 2661-6648
  • Email: frdemetr@uol.com.br

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-010
        • Recruiting
        • Institute of Psychiatry, University of Sao Paulo
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Diego F. Tavares, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    1) Partial responders or non-responders (HAM-D score > 7 points and/or YMRS > 9 points) in the ARIQUELI Study (after quetiapine + lithium or quetiapine + aripiprazole combination).

  • EXCLUSION CRITERIA:

    1. Patients with Schizophrenia, Schizoaffective Disorder or Mental Retardation (Intellectual Quotient Total less than 90);
    2. Patients with severe, unstable diseases, including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological;
    3. Hypo or hyperthyroidism uncorrected;
    4. Angle-closure glaucoma;
    5. Changes in blood coagulation or use of regular anticoagulants;
    6. Patients with serious risk of suicide (according to clinical criteria and / or score> = 4 in the HAM-D item suicide) may participate in the study only in inpatients;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Memantine
Patients randomized to this group will receive a dose of 15 mg / day of memantine during the first week (V0); all have the dose of memantine increased on the second week (V1) at the dose of 30 mg / day (in two divided doses of 15 mg).
Drug: Memantine
Memantine association in the treatment of young patients with Bipolar I Disorder, partial responders or non-responders to the combination of (quetiapine + lithium) or (quetiapine + aripiprazole) from the ARIQUELI study.
Other Names:
  • Namenda
  • Ebixa
Placebo Comparator: Placebo
Patients randomized to this group will receive a unit dosage identical to that contains 15 mg of memantine during the first week (V0); all have the dose of the placebo (similar to memantine) increased on the second week (V1) in two divided doses of a unit dosage identical to that contains 15 mg of memantine.
Drug: Placebo
Patients randomized to this group will receive a unit dosage identical to that contains 15 mg of memantine during the first week (V0); all have the dose of the placebo (similar to memantine) increased on the second week (V1) in two divided doses of a unit dosage identical to that contains 15 mg of memantine
Other Names:
  • Non active drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Memantine efficacy in stabilizing mood
Time Frame: 8 weeks

The primary outcome measure is to evaluate the memantine efficacy of the combination at 30 mg / day in stabilizing mood to therapy of young patients with Bipolar Disorder (type I) non-responders or partial responders to quetiapine combination with lithium or with aripiprazole from the ARIQUELI study. The definitions of the outcomes are:

  • Partial response: between 26% and 49% reduction from the baseline to the type of index episode (mania, mixed episode, depression), without further worsening of the opposite pole;
  • Response: ≥ 50% reduction from the baseline to the type of index episode (mania, mixed episode, depression) without further worsening of the opposite pole;
  • Remission: the used remission score is less than or equal to 9 of Young Mania Rating Scale (YMRS), equal or lower to 7 in Hamilton Depression Rating Scale (HAMD-21) reduction equal to or greater than 75% the inclusion scores in the study.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Memantine impact in the cognitive functioning
Time Frame: 24 weeks (6 months)
Improvement in the neuropsychological tests from baseline until the last observation carried forward in both groups (memantine x placebo).
24 weeks (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ricardo A. Moreno, MD, PhD, Sao Paulo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MORENO-2015

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