Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— CIT-PIN  

Official title:

Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931775
• Other study ID #: CIT-PIN_01-0C3
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: July 1, 2009
• Start date: December 2002
• Est. completion date: November 2005

Study information

• Verified date: July 2009
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.

Description:

Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with a depressive episode

• HDRS score > 18

• Written informed consent

Exclusion Criteria:

• suicidal risk > 3

• severe organic illness

• other psychotropic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antidepressant Treatment Response
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Pindolol
Pill orally administered. 15 mg/day t.i.d.

Locations

Country	Name	City	State
Spain	Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on Hamilton Depression Rating Scale		8 time points through 6 weeks	No