Protocol Number: 04-M-0227

Title:

Combining a Dopamine Agonist and Selective Serotonin Reuptake Inhibitor for Treatment of Depression: A Double-Blind, Randomized Study

Number:

04-M-0227

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Male or female subjects, 18 to 65 years of age.

2. Female subjects of childbearing potential must be using a medically accepted means of contraception.

3. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.

4. 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.

5. Subjects must have an initial score of greater than or equal to 20 on the MADRS at Visit 1 and Visit 2.

6. Subjects must not have a greater than a 25% decrease in the MADRS total scores during washout (between Visits 1 and 2).

7. 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).

8. Current major depressive episode of at least 4 weeks duration.

EXCLUSION CRITERIA:

9. Presence of psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder or bipolar disorder as defined in the DSM-IV.

10. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.

11. Previously failed to respond to an adequate trial (dose and duration) of escitalopram.

12. Female subjects who are either pregnant or nursing.

13. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

14. Subjects with uncorrected hypothyroidism or hyperthyroidism.

15. Subjects with one or more seizures without a clear and resolved etiology.

16. Previous treatment with pramipexole.

17. Treatment with a reversible MAOI within 2 weeks prior to Visit 2.

18. Treatment with fluoxetine within 5 weeks prior to Visit 2.

19. Treatment with any other concomitant medication not allowed (Appendix A) 7 days prior to study Visit 2.

20. Treatment with clozapine or ECT within 3 months prior to study Visit 2.

21. Judged clinically to be an acute suicidal risk.

22. Psychotherapy will not be permitted during the study.

Special Instructions:

Currently Not Provided

Keywords:

Pramipexole

Escitalopran

Antidepressant

Dopaminergic Receptor Agonist

Recruitment Keyword(s):

Depression

Major Depression

Condition(s):

Major Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Pramipexole

Drug: Escitalopram

Supporting Site:

National Institute of Mental Health

Contact(s):

Libby Jolkovsky
National Institutes of Health
Building 10
Room 7-5563
10 Center Drive
Bethesda, Maryland 20892
Phone: (877) 646-3644
Fax: (301) 402-9360
Electronic Address: libby_jolkovsky@nih.gov

Citation(s):

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

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

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/13/2009