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

NCT02630888 | Unknown Phase 2

• 1 other identifier: MORENO-2015
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Memantine; Lithium; Aripiprazole; Quetiapine; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Psychotropic Drugs; Cognitive effect of drugs

Outcome Measures

Primary Outcomes (1)

• Memantine efficacy in stabilizing mood

  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 Outcomes (1)

• Memantine impact in the cognitive functioning

  24 weeks (6 months)

Study Arms (2)

Memantine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Memantine DRUG

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.

Also known as: Namenda, Ebixa

Memantine

Placebo DRUG

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

Also known as: Non active drug

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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).

You may not qualify if:

• Patients with Schizophrenia, Schizoaffective Disorder or Mental Retardation (Intellectual Quotient Total less than 90);
• Patients with severe, unstable diseases, including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological;
• Hypo or hyperthyroidism uncorrected;
• Angle-closure glaucoma;
• Changes in blood coagulation or use of regular anticoagulants;
• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry, University of Sao Paulo

São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ricardo A. Moreno, MD, PhD

  Sao Paulo University

  STUDY DIRECTOR

Central Study Contacts

Ricardo A. Moreno, MD, PhD

CONTACT

+55 (11) 2661-6648; ricardoalbertomoreno@gmail.com

Frederico N. Demetrio, MD, PhD

CONTACT

+55 (11) 2661-6648; frdemetr@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affective disorders program (GRUDA)

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 15, 2015
• Study Start: August 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

BR (1)