NCT05098353

Brief Summary

In this study, the task was to evaluate the effectiveness of prescribing small doses of quetiapine (25-75 mg) for bipolar patients in remission in order to relieve symptoms of impulsivity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

September 13, 2021

Last Update Submit

October 18, 2021

Conditions

Bipolar Affective Disorder

Keywords

Bipolar Affective Disorder remissionImpulsivityBarrat scaleGo-no-goBARTBallon Analog Risk TaskQuetiapine

Outcome Measures

Primary Outcomes (3)

  • Statistically significant changes in Barratt Impulsiveness Scale

    Statistically significant changes in Barratt Impulsiveness Scale from visit 1 to visit 3. Minimum score for this scale is 55, maximum score is 120, higher scores mean worse outcome.

    6 weeks of treatment

  • Statistically significant changes in total earnings score of Ballon Analog Risk Task (BART)

    In Ballon Analog Risk Task (BART) participants should earn as many points as they can during task. Total score is major parameter, measured in points, more points means better outcome.

    6 weeks of treatment

  • Statistically significant changes in dprime parameter in Go-no-Go task

    In Go-no-Go task participants should push the button on keyboard whan they see certain pictures and dont push when there see any other pictures. Dprime is major parameter which summarizes number of right and wrong answers, measured in points, more points means better outcome.

    6 weeks of treatment

Study Arms (1)

Quetiapine 25-75 mg

EXPERIMENTAL

There is one arm in this study. Patients will take quetiapine in dose 25-75 1-3 times a day. Dose and its frequency can be adjusted by researcher during first 2 weeks (till visit 2), after that patients will take stable dose of quetiapine till week 6 (visit 3).

Drug: Quetiapine

Interventions

QuetiapineDRUG

25-75 mg per day for 6 weeks

Also known as: Quetiapine - impulsivity
Quetiapine 25-75 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Availability of written informed consent to participate in the Program.
  • The established diagnosis of bipolar disorder in incomplete remission and the presence of violations in the field of impulse control (score on the Barratt scale above 70 points)
  • Age from 18 to 65 years inclusive;
  • The patient's desire and ability to participate in the study and follow the doctor's instructions.

You may not qualify if:

  • The presence of quetiapine intolerance in the anamnesis.
  • The presence of an actual active phase of bipolar disorder: depression (MADRS score above 22 points) or mania (YMRS score above 20 points).
  • Hypersensitivity to the components of quetiapine in the anamnesis;
  • Current clinically significant and unstable somatic diseases.
  • Participation in other observational programs or clinical trials during the conduct of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental health research center

Moscow, 115522, Russia

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderImpulsive Behavior

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Margarita A Morozova, PhD

    Federal Stare Budgetary Scientific Institution, Mental Health Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita A Morozova, PhD

CONTACT

+74951090393margmorozova@gmail.com

Sergey S Potanin, PhD

CONTACT

+74951090393potanin_ss@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of laboratory of psychopharmacology, PhD,

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 28, 2021

Study Start

April 10, 2021

Primary Completion

November 15, 2021

Study Completion

December 1, 2021

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)