NCT01411566

Brief Summary

The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

March 2, 2011

Last Update Submit

August 5, 2011

Conditions

PsychosisSubstance Abuse

Keywords

KLIPS

Outcome Measures

Primary Outcomes (6)

  • Substance use

    one year

  • Substance use

    3 months

  • Substance use

    6 months

  • Change in drug use motivation

    3 months

  • Change in drug use motivation

    6 months

  • Change in drug use motivation

    1 year

Study Arms (2)

Treatment

EXPERIMENTAL
Behavioral: Skills trainig for patients with dual diagnosis

Control

ACTIVE COMPARATOR
Behavioral: regular treatment

Interventions

Skills trainig for patients with dual diagnosisBEHAVIORAL

Skills trainig for patients with dual diagnosis

Treatment
regular treatmentBEHAVIORAL

regular treatment

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia
  • Addiction
  • Written statement of agreement
  • Majority

You may not qualify if:

  • Acute psychosis
  • Further neuropsychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LVR Clinic Cologne - Academic Clinic of the University of Cologne

Cologne, 51109, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersSubstance-Related Disorders

Interventions

mica

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Joerg Daumann, PhD

    University of Cologne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2011

First Posted

August 8, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-02

Locations

DE(1)