Method for the diagnosis of depression based on monitoring blood levels of arginine vasopressin and/or thymopoietin

• US 5,591,588 A
• Filed: 09/20/1994
• Issued: 01/07/1997
• Est. Priority Date: 09/20/1994
• Status: Expired due to Fees

• Current Assignee: Thymon LLC
• Original Assignee: Gideon Goldstein
• Inventors: Goldstein, Gideon, Culler, Michael D.
• Primary Examiner(s): Knode, Marian C.
• Assistant Examiner(s): DUFFY, PATRICIA ANN
• Application Number:
  US08/309,420
• Time in Patent Office: 840 Days
• Field of Search: 435/7.92, 435/7.93, 435/7.94, 435/7.95, 435/7.1, 435/961, 435/962, 435/967, 435/975, 436/518, 436/86, 436/87, 436/174, 436/175, 436/176, 436/177, 436/804, 436/811
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2800/304 Mood disorders, e.g. bipolar, depression
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: Y10S 435/961 including a step of forming, releasing, or exposing the antigen or forming the hapten-immunogenic carrier complex or the antigen per se
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

The invention provides a novel means of diagnosing, or confirming a diagnosis of, affective disorders, such as depression, based on the blood levels of arginine vasopressin and thymopoietin, either alone or in combination.

Claims

1. A method for aiding the diagnosis of depression in humans, comprising:

providing a sample of serum or plasma from a first human subject suspected of having depression;

providing a range of arginine vasopressin (AVP) levels previously obtained from normal control subjects;

dissociating the AVP in the sample from its neurophysin carrier protein; and

measuring the level of AVP in said first subject'"'"'s sample by immunoassay,

wherein detection of an AVP level in said first subject'"'"'s sample which is statistically elevated over said normal control range is indicative of depression.

4. The method according to claim 1 wherein said sample is obtained from said first subject in the afternoon.

2. A method for aiding the diagnosis of depression in humans, comprising:

providing a sample of serum or plasma from a first human subject suspected of having depression;

providing a range of thymopoietin (TP) levels previously obtained from normal control subjects;

dissociating the TP in the sample from its complexing protein; and

measuring the level of TP in said first subject'"'"'s sample in a immunoassay,

wherein detection of a TP level in said first subject'"'"'s sample which is statistically elevated over said normal control range is indicative of depression.

5. The method according to claim 2 wherein said sample is obtained from said first subject in the afternoon.

3. A method for aiding the diagnosis of depression in humans, comprising the steps of:

(a) providing a sample of whole blood, serum or plasma from a first human subject suspected of having depression;

(b) analyzing the arginine vasopressin (AVP) levels and thymopoietin (TP) levels previously obtained from normal and depressed control subjects in a two parameter logistic regression analysis to obtain a combined value which indicates the cutoff point between normal and depressed subjects;

(c) dissociating the AVP from its neurophysin carrier protein and dissociating the TP in the sample from its complexing protein;

(d) measuring the levels of AVP and TP in said first subject'"'"'s sample in immunoassays;

(e) combining the values of step (d); and

(f) comparing the value of step (e) to said cutoff value, wherein a value of step (e) which is statistically elevated over said cutoff value indicates a diagnosis of depression.

6. The method according to claim 3 wherein said sample is obtained from said first subject in the afternoon.

7. A diagnostic kit useful as an aid in a diagnosis of depression comprising the anti-arginine vasopressin (AVP) antibodies and immunoassay components for the measurement of AVP levels in plasma or serum and anti-thymopoietin (TP) antibodies, reagents necessary to dissociate TP from its complexing protein, and the immunoassay components for the measurement of TP in plasma or serum.

8. The kit according to claim 7 further comprising reagents necessary to dissociate AVP from its neurophysin carrier protein.