Treatment-resistant depression Mental and Behavioural Disorders Other depressive episodes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female primary care patients between 18 to 65 years of age 2. Major depressive disorder or dysthymia based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and minimum symptom severity on the Beck Depression Inventory (BDI) of 21 or above and 14 or above on the Hamilton Rating Scale for Depression (HRSD) 3. Minimum of a two-year history of depression 4. Atleast two previous failed treatment attempts, one of which was with an anti-depressant 5. Able to speak conversational English and be seen at the Tavistock Clinic, London 6. Willing to enter a randomised controlled trial
Exclusion criteria
Exclusion criteria: Primary care patients with: 1. Recent (previous five years) history of psychosis 2. Recent (previous five year) history of bi-polar disorder 3. Moderate or severe learning disabilities 4. Recent history (previous two years) of psychiatric input for, or diagnosis of, substance dependency (alcohol abuse more than 21 units/week; drug abuse more than 4/week) 5. Patients currently in psychological therapy 6. Patients who have received psychoanalytic psychotherapy in the previous two years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in depression severity as indicated by the independent, double-rated Hamilton Rating Scale of Depression (HRSD, Hamilton, 1967) at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up. It is a semi-structured interview consisting of 21 depression items, which yield a range of scores from 0 - 62. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-report depression severity: assessed using the Beck Depression Inventory (BDI II, Beck et al, 1996). It consists of 21 items, which yield a range of scores from 0 to 63. Each items is to be scored on a Likert-scale ranging from 0-3 (0 = depression symptom not present, 3 depression symptom severe). It is assessed at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months,6 months follow-up, 12 months follow-up and 24 months follow-up 2. Axis I disorders: assessed using the Structured Clinical Interview for DSM IV, research version (SCID-I, First et al, 2001). This semi-structured clinical interview assesses subjects on all five axes of DSM IV diagnosis. The diagnoses assessed in the TADS trial are Major depressive disorder (MDD), dysthymia, alcohol abuse/dependency, drug abuse/dependency, anxiety disorders, obsessive?compulsive disorder (OCD), and eating disorders. It is assessed and blindly double-rated at baseline, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 3. Axis II personality disorders (PD): the Structured Clinical Interview for DSM IV Personality Disorders Questionnaire (SCID-II-PQ. First et al., 1997)) is used to identify patients with probable Axis II disorders. It is a self-report measure asking for a yes or no response to 104 questions. It is assessed and blindly double-rated at baseline, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 4. Personality functioning: the information yielded by the Tavistock Psychodynamic Interview (TPI) carried at baseline and six-months follow-up allows Axis-II pathology to be assessed with the Shedler-Westen Q-Sort, Shedler and Westen, 2004. The information also permits the assessment of personality pathology according to the revised criteria of the proposed DSM-V. Will be assessed and blindly double-rated at baseline and 6 months follow-up 5. Object relations: assessed using the Persons Relating to Others Questionnaire (PROQ2a, Birtchnell, | — |
Countries
United Kingdom