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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

44

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

University of Sao Paulo

Investigators

  • 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)

August 1, 2014

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORENO-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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