Protocol Number: 06-M-0215

Title:

Antidepressant Effects on cAMP Specific Phosphodiesterase (PDE 4) in Depressed Patients

Number:

06-M-0215

Summary:

The primary purpose of this protocol is to compare PDE4 levels before and after starting a selective serotonin reuptake inhibitor (SSRI) sertraline, citalopram or escitalopram in unmedicated depressed patients. The secondary purpose is to compare PDE4 levels between unmedicated depressed patients and healthy subjects.

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:

Healthy Volunteers (n=20)

Healthy Control Sample (n=20): Healthy subjects (ages 18-55) will be selected who have not met criteria for any major psychiatric disorder, have no known first-degree relatives with mood disorders, and have a current score on the Hamilton Depression Rating Scale (HDRS; 17 item) in the not depressed range (less than or equal to 7). Control subjects will be matched to depressed subjects for age and gender.

MDD Samples (n=30)

MDD Sample-Currently Depressed (n=30): Patients (ages 18-55) will be selected with primary MDD currently depressed by DSM-IV criteria for recurrent MDD and current HDRS score in the moderately-to-severely depressed range (greater than or equal to 18). All subjects must be healthy and aged 18-55 years.

EXCLUSION CRITERIA:

Subjects will be recruited who are drug-naive or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Effective medications will not be discontinued for the purposes of the study.

Subjects will also be excluded if they have:

- Serious suicidal ideation or behavior

- Psychosis

- Medical conditions or concomitant medications that are likely to influence PET measurement or have significant interactions with sertraline, citalopram or escitalopram

- Previously proved unresponsive to a therapeutic trial of sertraline, citalopram or escitalopram

- Previously developed allergic reactions to sertraline, citalopram or escitalopram, or discontinued each of these medications due to an adverse effect

- A history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM-IV criteria)

- Current pregnancy (as documented by pregnancy testing prior to scanning)

- General MRI exclusion criteria

- Major depression that arose following another major medical or psychiatric condition

- Prior participation in other research protocols within a year such that radiation exposure would exceed annual guidelines

Additional exclusion criteria applied to control subjects are:

- Subjects with a current or past history of other axis I psychiatric conditions

- Subjects with first-degree family members with current or past history of mood disorder

- Subjects who are smokers

Special Instructions:

Currently Not Provided

Keywords:

Unipolar Depression

Phosphorylation

Affinity States

Compartment Analysis

(R)-(11)C rolipram

Recruitment Keyword(s):

Depression

Major Depressive Disorder

MDD

Healthy Volunteer

HV

Condition(s):

Major Depressive Disorder

Healthy

Investigational Drug(s):

Rolipram

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: PET scan

Drug: Rolipram

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Andersen PH, Klysner R, Geisler A. Cyclic AMP phosphodiesterase activity in rat brain following chronic treatment with lithium, imipramine, reserpine, and combinations of lithium with imipramine or reserpine. Acta Pharmacol Toxicol (Copenh). 1983 Oct;53(4):337-43.

Blier P, de Montigny C. Current advances and trends in the treatment of depression. Trends Pharmacol Sci. 1994 Jul;15(7):220-6. Review.

Conti M, Nemoz G, Sette C, Vicini E. Recent progress in understanding the hormonal regulation of phosphodiesterases. Endocr Rev. 1995 Jun;16(3):370-89. Review. No abstract available.

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