Pharmacological treatment of Depression: Phase II Lithium addition
| ISRCTN | ISRCTN75768415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75768415 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 28/04/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W.W. Broek, van den
Scientific
Scientific
Erasmus Medical Center
Department of Psychiatry
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| w.w.vandenbroek@erasmusmc.nl |
Study information
| Study design | A double blind, randomized single-centre study with a washout period, comparing 2 treatment strategies. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The two strategies (Venlafaxine and subsequent Lithium addition in non-responders to Venlafaxine; Imipramine and subsequent Lithium addition in non-responders to Imipramine) are comparable in efficacy and time to response. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Venlafaxine (maximum dose 375 mg) and subsequent Lithium addition; Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l) and subsequent Lithium addition. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Venlafaxine, Lithium, Imipramine |
| Primary outcome measure | 1. Change in HRSD scores 2. Change in CGI scores |
| Secondary outcome measures | Adverse effects. |
| Overall study start date | 01/06/2005 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 69 |
| Key inclusion criteria | All non-responders in phase I. In phase I inclusion criteria were: 1. Age 18-65 2. Major depressive disorder, single or recurrent episode (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) 3. Hamilton Rating Scale for Depression (HRSD) (17 item) greater than or equal to 14 4. Written informed consent |
| Key exclusion criteria | Any of the following is regarded as a criterion for exclusion from the trial: 1. Patients who are incapable of understanding the information and of giving informed consent. Also, patients who are unable to read or write 2. Major depression with psychotic features (separate study) 3. Bipolar I or II disorder 4. Schizophrenia or other primary psychotic disorder 5. Treatment of current episode with adequate trial of Imipramine or Venlafaxine 6. Drug/alcohol dependence in the last 3 months 7. Mental retardation (IQ <80) 8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding. 9. Serious medical illness affecting central nervous system (CNS) e.g. M. Parkinson, systemic lupus erythematosus (SLE), brain tumor, cerebrovascular accident (CVA) 10. Relevant medical illness as contra-indications for the use of study medication (Venlafaxine and Imipramine), such as recent myocardial infarction and severe liver or kidney failure 11. Medication affecting CNS e.g. antidepressants and/or antipsychotics other than study medication, steroids (prednison), mood stabilisers, benzodiazepines (if not being tapered): >3 mg lorazepam (or equivalent) 12. Direct electroconvulsive therapy (ECT) indication (e.g. very severely suicidal or refusal of food and drinking resulting in life threatening situation) 13. Contra-indications for Lithium (Moleman, 1998): a. Kidney failure b. Acute myocardial infarction c. Myasthenia gravis d. Breastfeeding |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
University/education
University/education
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Industry
Wyeth
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
