NCT00231959

Brief Summary

This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Sep 2003

Typical duration for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

4 years

First QC Date

September 30, 2005

Last Update Submit

April 25, 2012

Conditions

Depression

Keywords

Depression, Treatment-Resistant

Outcome Measures

Primary Outcomes (2)

  • Score on the Montgomery-Asberg Depression Rating Scale

    Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders

  • Clinical Global Impressions (CGI) scale

    Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Pramipexole

EXPERIMENTAL
Drug: Pramipexole (Mirapex)

Interventions

Pramipexole (Mirapex)DRUG

pramipexole 0.5mg tablets qd and titrated per protocol

Pramipexole
PlaceboDRUG

sugar pill

Sugar pill

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets diagnostic criteria for major depressive disorder
  • Meets criteria for current major depressive episode
  • Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
  • Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
  • Agrees to use an effective form of contraception throughout the study

You may not qualify if:

  • Pregnant
  • At risk for suicide or homicide
  • Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
  • History of a substance use disorder within 6 months of study enrollment
  • History of or current psychotic features
  • Currently being treated with typical or atypical antipsychotic medications
  • Currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
  • Clinical or laboratory evidence of untreated hypothyroidism
  • History of a 2-week or longer course of pramipexole
  • Intolerance of pramipexole at any dose
  • Any investigational psychotropic drug use within the last three months
  • Level 3 or greater antidepressant resistance as assessed by the ATHF
  • Three or more episodes of self-harm in the year prior to study enrollment
  • Documented history of poor treatment adherence or frequently missed appointments
  • Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Cusin C, Iovieno N, Iosifescu DV, Nierenberg AA, Fava M, Rush AJ, Perlis RH. A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. J Clin Psychiatry. 2013 Jul;74(7):e636-41. doi: 10.4088/JCP.12m08093.

    PMID: 23945458DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Treatment-Resistant

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Roy Perlis, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Experimental Drugs and Diagnostics

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

September 1, 2003

Primary Completion

September 1, 2007

Study Completion

April 1, 2008

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

US(1)