Lexapro and Pramipexole and to Treat Major Depression

NCT00086307 | Completed Phase 2 Results

• 2 other identifiers: 04022704-M-0227
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study. Candidates must currently be in a major depressive episode of at least 4 weeks' duration, have failed to respond to treatment with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more than four antidepressants for the current episode. Candidates are screened with a physical examination, psychiatric evaluation, blood tests, review of vital signs, height and weight measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for women. Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment. They are then randomly assigned to take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks. During the study, participants come to the clinic eight times for health assessments and symptoms assessments, which include a check of vital signs and rating scales for depression and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected periodically to monitor health, detect pregnancy in women, and detect illicit drug use. At the end of the 6-week treatment period, participants have a physical examination, ECG, blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and plans are made for long-term treatment. Atendemos pacientes de habla hispana. ...

Conditions

Major Depression

Keywords

Pramipexole; Escitalopran; Antidepressant; Dopaminergic Receptor Agonist; Depression; Major Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.

  Weekly

Study Arms (3)

Pramipexole

ACTIVE COMPARATOR

Patients receive pramipexole and placebo. The dosage of pramipexole is 0.125 milligrams (mg) three times per day in the first week, 0.250 mg three times per day in the second week, 0.5 mg three times per day in the third week, and 0.75 mg three times per day in the fourth week and thereafter.

Drug: Pramipexole

Escitalopram

ACTIVE COMPARATOR

Patients receive escitalopram and placebo. The dosage of escitalopram is 10 milligrams (mg) per day.

Drug: Escitalopram

Escitalopram and Pramipexole

EXPERIMENTAL

Patients receive escitalopram and pramipexole. The dosage of escitalopram is 10 milligrams (mg) per day. The dosage of pramipexole is 0.125 mg three times per day in the first week, 0.250 mg three times per day in the second week, 0.5 mg three times per day in the third week, and 0.75 mg three times per day in the fourth week and thereafter.

Drug: Pramipexole; Drug: Escitalopram

Interventions

Pramipexole DRUG

Pramipexole will be titrated so patients receive the following medication three times per day during the weeks noted: .125 milligrams (mg) in week 1, .250 mg in week 2, .5 mg in week 3, and .75 mg in weeks 4 to 6.

Escitalopram and Pramipexole; Pramipexole

Escitalopram DRUG

Escitalopram will be started at 10 mg/day and patients will continue on this throughout the study.

Escitalopram; Escitalopram and Pramipexole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 to 65 years of age.
• Female subjects of childbearing potential must be using a medically accepted means of contraception.
• Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
• Subjects must fulfill DSM-IV criteria for Major Depression (296.33) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
• Subjects must have an initial score of greater than or equal to 20 on the MADRS at Visit 1 and Visit 2.
• Subjects must not have a greater than a 25% decrease in the MADRS total scores during washout (between Visits 1 and 2).
• Current or past history of lack of response to at least one adequate antidepressant trial (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF) (Sackeim 2001b). If this criteria has not been met, a four-week prospective trial of a standard antidepressant (at the patients' and clinicians' discretion) may be given. Subjects are excluded if greater than four failed antidepressant trials for the current major depressive (adequate dose and duration as defined by the ATHF).
• Current major depressive episode of at least 4 weeks duration.

You may not qualify if:

• Presence of psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder or bipolar disorder as defined in the DSM-IV.
• Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
• Previously failed to respond to an adequate trial (dose and duration) of escitalopram.
• Female subjects who are either pregnant or nursing.
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Subjects with uncorrected hypothyroidism or hyperthyroidism.
• Subjects with one or more seizures without a clear and resolved etiology.
• Previous treatment with pramipexole.
• Treatment with a reversible MAOI within 2 weeks prior to Visit 2.
• Treatment with fluoxetine within 5 weeks prior to Visit 2.
• Treatment with any other concomitant medication not allowed (Appendix A) 7 days prior to study Visit 2.
• Treatment with clozapine or ECT within 3 months prior to study Visit 2.
• Judged clinically to be an acute suicidal risk.
• Psychotherapy will not be permitted during the study.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Agnoli A, Ruggieri S, Casacchia M. Restatement and prospectives of ergot alkaloids in clinical neurology and psychiatry. Pharmacology. 1978;16 Suppl 1:174-88. doi: 10.1159/000136818. No abstract available.

  PMID: 347463 BACKGROUND

• Anderson IM. SSRIS versus tricyclic antidepressants in depressed inpatients: a meta-analysis of efficacy and tolerability. Depress Anxiety. 1998;7 Suppl 1:11-7.

  PMID: 9597346 BACKGROUND

• Agren H, Mefford IN, Rudorfer MV, Linnoila M, Potter WZ. Interacting neurotransmitter systems. A non-experimental approach to the 5HIAA-HVA correlation in human CSF. J Psychiatr Res. 1986;20(3):175-93. doi: 10.1016/0022-3956(86)90002-6.

  PMID: 2430098 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Pramipexole; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans

Results Point of Contact

• Title: Dr. Carlos A. Zarate
• Organization: NIMH

zaratec@mail.nih.gov

301-451-0861

Study Officials

• Carlos A Zarate, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Experimental Therapeutics and Pathophysiology Branch of NIMH, DIRP

Study Record Dates

• First Submitted: June 29, 2004
• First Posted: June 30, 2004
• Study Start: June 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 28, 2013
• Results First Posted: July 12, 2012

Record last verified: 2013-01

Locations

US (1)