Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder (CIT-PIN)

This study has been completed.
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00931775
First received: July 1, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Antidepressant Treatment Response
Drug: Pindolol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Scores on Hamilton Depression Rating Scale [ Time Frame: 8 time points through 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2002
Study Completion Date: November 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Citalopram + placebo
Citalopram 20 mg/day t.i.d
Drug: Pindolol
Pill orally administered. 15 mg/day t.i.d.
Experimental: Citalopram + pindolol
Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d.
Drug: Pindolol
Pill orally administered. 15 mg/day t.i.d.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a depressive episode
  • HDRS score > 18
  • Written informed consent

Exclusion Criteria:

  • suicidal risk > 3
  • severe organic illness
  • other psychotropic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931775

Locations
Spain
Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Enric Álvarez, MD, PhD Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Study Director: Víctor Pérez, MD, PhD Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Study Chair: Francesc Artigas, PhD Neurochemistry department. Consejo Superior de Investigaciones Científicas
  More Information

No publications provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Enric Álvarez / Víctor Pérez, Hospital de la Santa Creu i Sant Pau. Psychiatry Department
ClinicalTrials.gov Identifier: NCT00931775     History of Changes
Other Study ID Numbers: CIT-PIN_01-0C3
Study First Received: July 1, 2009
Last Updated: July 1, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Major depressive disorder, citalopram, pindolol, HDRS

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Pindolol
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014